Feb 2015

CONVENTION ISSUE:

Minimally Invasive Surgery Symposium

GENERALSURGERYNEWS.COM

February 2015 • Volume 42 • Number 2

The Independent Monthly Newspaper for the General Surgeon

Opinion

A New Horizon for Bariatric Surgery:

The ‘Perioperativists’ Are Coming!

Reducing Readmission Rates BY

Proper Setup Might Ease Burden; Some Data Show Benefits of Single-Incision Surgery

B Y F REDERICK L. G REENE , MD

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fascinating trend in medicine that has developed during the past decade or two is the expansion of certain specialties and the creation of diverse kinds of specialists in order to fill needs abandoned by other groups of physicians.

“Intensivists” have proliferated as critical care medicine has become more complex and as many physicians have been encouraged to abdicate intensive care unit management to others.

The concept of the “hospitalist” evolved because of the desire of many internal medicine specialists to avoid taking hospital call or making rounds in the inpatient hospital setting.

Radiologists and cardiologists expanded their turf and became “interventionalists” to provide services traditionally offered by cardiac and vascular surgeons.

The “laborist” appeared as obstetricians eschewed traditional call responsibility for deliveries and encouraged hospitals and obstetrical practices to hire

B Y C HRISTINA F RANGOU

C HRISTINA F RANGOU SAN FRANCISCO—With the risk for death from bariatric surgery now as low as that for knee replacement surgery, the bariatric surgery community has set its sights on a new goal: reducing readmissions after bariatric surgery.

“Our next horizon is targeting readmissions, specifically, reducing

Pullout Section Page 13

readmissions within 30 days by 20% nationally,” said John Morton, MD, president of the American Society for Metabolic and Bariatric Surgery and director of bariatric surgery, Stanford University School of Medicine, in Stanford, Calif.

In a presentation at the 2014 Clinical Congress of the American College of Surgeons (ACS), Dr. Morton reported see READMISSIONS page 32

Say Hello to the Smapp: A New Trend in Medical Innovation B Y P AUL A LAN W ETTER , MD

see PERIOPERATIVISTS page 3

EXTENDED HERNIA COVERAGE

O

ur ability to communicate globally has increased at a lightning pace. Within seconds of completion, my thoughts can travel around the world. This is a new era of innovation, communication, technology and science that is fostering a

Surgeons’ Lounge

On the Spot

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Colleen Hutchison tests some leading experts on hot topics in hernia repair

In the News General Surgery News Now Offers Video Coverage See page 11

SAN FRANCISCO—If you’re rubbing your neck as you read this, a recent study’s results will come as no surprise: Although patients may seem more satisfied with single-incision laparoscopic cholecystectomy than with the four-port laparoscopic procedure, surgeons experience more physical discomfort and awkwardness, with less ability to perform fine-precision motions, according to results from a unique randomized controlled trial.

“Although patient satisfaction is improved with single-site cholecystectomy, physician workload is significantly increased,” said study co-author Amani O. Mohamed, MD, a surgical resident at Mayo Clinic, Rochester, Minn.

Dr. Mohamed presented the study at the 2014 Clinical Congress of the American College of Surgeons.

Surgeons experience an 89% increase in physical workload while performing see SINGLE-INCISION page 38

rapid dissemination of new ideas from basic sciences to advanced technologies.

As a young man in the early 1970s, I worked in a bank where there was a great deal of excitement about a new

INSIDE Robotic Repair of Ventral Hernias

Ouch! SingleIncision Procedures Can Stress Surgeons

see SMAPPS page 36

ISSUES FOR THE BARIATRIC & METABOLIC PROFESSIONAL

Extended Quarterly Coverage Section begins on page 29

Question the norm.

Do the tools you need exist today?

According to us, the answer is no. But each new device takes us closer.

Zenapro, for instance, is the first hybrid hernia-repair device. A sheet of ultra-lightweight polypropylene mesh surrounded by extracellular matrix, Zenapro gives patients a permanent repair while leaving behind minimal foreign material in the body.

Learn more: visit zenapro.cookmedical.com.

Zenapro Hybrid Hernia Repair Device ™

www.cookmedical.com Š COOK 11/2014 D15408-EN-F

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

PERIOPERATIVISTS jContinued from page 1

physicians who sought hospital-based and shift-based practices.

The “surgicalist” emerged in a similar fashion as the exigencies of acute-care surgery and the presumed burden of unassigned emergency department patients changed the mindset of many surgeons regarding hospital call.

These examples of “specialist” expansion and “turf creep” have generally occurred because of the perceived needs of patients and the medical community or as responses to the unwillingness of certain specialties to continue to provide traditional care.

Recently, I came across a new paradigm of this phenomenon: the “perioperativist.” This new creation emanates from the anesthesiology community as an expression that the anesthesiologist is the most appropriate person to have total oversight over the preoperative, intraoperative and postoperative phases of the care of the surgical patient.

I certainly recognize that the preoperative assessment is improved when coordinated with anesthesia personnel who counsel patients regarding current medications and the potential risks of anesthesia associated with certain comorbidities. The American Society of Anesthesiology (ASA) is now advocating the concept of the “perioperativist” and the Perioperative Surgical Home (PSH; see www.asahq.org) and espouses the concept that in the name of safety, economy and overall efficiency, management of operative patients should

be coordinated in a multidisciplinary fashion and that this approach should be led by the anesthesiologist. The “perioperativist,” by definition, is the anesthesiologist who will provide overall support in all phases for the surgical patient.

It appears that some in the anesthesia community believe that surgeons are not capable of or have abdicated their role in the management of the perioperative patient. This includes dispensing information in

Our anesthesiology colleagues believe that the … best specialist to coordinate this overarching activity is the anesthesiology-created “perioperativist.” the preoperative setting as well as providing appropriate post-anesthesia care and other postoperative supervision regarding perioperative drug management, pain control and even recommendations for postoperative activity.

I certainly agree that a coordinated multidisciplinary approach for the patient undergoing an operation is both reasonable and beneficial. The PSH should be a patient-centered, physician-led, multidisciplinary team–based model of coordinated care. The preoperative, intraoperative, immediate postoperative and postdischarge care should be fully coordinated and treated as a continuum of care.

My concern, however, is that in this model, the surgeon is marginalized while the anesthesiologist assumes the role of the “perioperativist” in ensuring that all of these phases are coordinated. The president of the ASA opined that “physician anesthesiologist–led anesthesia care teams are associated with better patient outcomes, fewer complications, less pain, earlier return to functionality and home, and lower costs” (ASA website, December 2014). Our anesthesiology colleagues believe that the best specialty and best specialist to coordinate this overarching activity is the anesthesiology-created “perioperativist.”

The creation of new specialty models and physician genres has generally occurred because of abdication of certain responsibilities and traditional roles previously provided by physicians and specialties. I would certainly not want to see the role of the operating surgeon sequestered solely into the technical phase of an operation while leaving the preparation, education and postoperative management of patients to the nonsurgical “perioperativist.” Although some facets of the PSH are appealing, the overall management of the surgical patient must not transition to nonsurgical specialists because of the presumption that we have undervalued or abdicated our responsibility for coordinating the care of the surgical patient. The operating surgeon should and must remain the captain of the entire ship!

—Dr. Greenee is clinical professor of surgery, UNC School — of Medicine, Chapel Hill, North Carolina. He serves as the senior medical adviser for General Surgery News.

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Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

Dear Readers, Welcome to the February issue of The Surgeons’ Lounge. In keeping with the theme of this issue, our guest experts Eduardo Parra-Davila, MD, director of Minimally Invasive and Colorectal Surgery, director of Hernia and Abdominal Wall Reconstruction, Celebration Health, Florida Hospital, Kissimmee, FL and Conrad Ballecer, MD, MS, co-director of the Center for Minimally Invasive and Robotic Surgery, Arrowhead Hospital and Banner Thunderbird Medical Center, Glendale, Ariz., will be discussing robotic repair of ventral hernias. We welcome your questions and comments!

Sincerely, Dr. Szomstein n is associate Samuel Szomstein, MD, FACS director, Bariatric Institute, Editor, the Surgeon’s Lounge Section of Minimally Invasive Surgery, Department of General Szomsts@ccf.org and Vascular Surgery, Cleveland Clinic Florida, Weston.

Question for Eduardo Parra-Davila, MD, and Conrad Ballecer, MD Carlos Hartmann, MD, staff surgeon Centro Medico Guerra Mendez, Valencia, Venezuela

There has been an increase in robotic technology involved in the repair of ventral hernias in the past year.

• Why do you use the da Vinci robot in the repair of ventral hernias?

• • •

Is it easier to close the hernia defect robotically?

Where can the mesh be placed robotically to reinforce the repair?

Can robotics facilitate the bilateral component separation technique described as posterior transverse release?

Drs. Parra-Davila and Ballecer’s

Reply

In 2004, the American Hernia Society concluded in their consensus statement that the Rives-Stoppa repair of ventral hernias was the standard by which all open hernia repairs should be judged (Surg Clin North Am 2008;88:1083-100; Am J Surg 2012;204:709-716). Although shown to be a durable repair, wound complications oftentimes result in unacceptable patient morbidity. To decrease wound morbidity, laparoscopic ventral hernia repair (LVHR) emerged and resulted in negligible wound morbidity and low recurrence rates (Ann ( Surgg 2003;238:391-399).

Laparoscopic repair of incisional hernias was first introduced in 1992, leading to improved recovery time and reductions in hospital length of stay, complication rates and cost (Ann ( Surgg 2003;238:391399; Surgeryy 2005;138:708-715). Published recurrence rates have been reduced to less than 9% (Surg Endoscc 1999;13:250252; Surg Laparosc Endoscc 1998;8:294299; Surg Endoscc 2000;14:419-423; J Am Coll Surgg 2000;190:645-650). These recurrences have been attributed mainly to improper positioning of the mesh (with <3 cm overlap of mesh and fascia)

and to the use of tacking or stapling devices for fixation rather than abdominal wall suturing using suture passers (J ( Am Coll Surgg 2000;190:645-650; Am J Surg 1999;177:227-231).

Although laparoscopic repair has been associated with faster recovery, fewer complications and a lower recurrence rate compared with the open technique, there continues to be a significant incidence of postoperative pain associated with the transabdominal wall sutures. Several authors have reported a 2% incidence of significant postoperative pain lasting more than two to eight weeks after repair (Surg Endoscc 2000;14:419-423; JSLS 2003;7:7-14; Surg Endoscc 2006;20:7175; World J Surgg 2012;36:447-452; Am Surgg 2006;72:808-813; J Gastrointest Surg 2004;8:670-674). Significant postoperative pain has also been described in association with tacks. The pain is described by patients as a point of constant burning in a dermatome pattern at the points of transabdominal sutures or tacks, and has been attributed to tissue and nerve entrapment.

The da Vinci robot (Intuitive Surgical) offers numerous advantages over

laparoscopy, including several degrees of motion, three-dimensional imaging, and superior ergonomics that enables easy and precise intracorporeal suturing. Other reports have demonstrated the ease of intracorporeal suturing of the mesh to the abdominal wall ((JSLS S 2003;7:7-14).

Thus, this device is an ideal tool for intracorporeal suturing of mesh to the posterior fascia of the anterior abdominal wall for ventral hernia repair. Whereas previous reports have confirmed the need to suture the mesh at 2- to 5-cm intervals as a means of reducing the recurrence rates associated with laparoscopic hernia repairs, we believe that continuous circumferential suturing applies those principles while evenly distributing the tension throughout the mesh (Surg Endoscc 2000;14:419-423; J Am Coll Surgg 2000;190:645-650; Am J Surgg 1999;177:227-231).

The entire repair is performed under direct visualization, with precise placement and confirmation of depth into the posterior fascia for all sutures placed. The fascial sutures encompass 1-cm bites of fascia, minimizing trauma to the abdominal wall.

Intracorporeal suturing of the fascia allows the midline to be reapproximated, facilitating possible primary repair, more physiologic abdominal wall movement and greater overlap of the mesh to the defect’s fascial edges. Robot-assisted LVHR offers yet another advantage by providing the suturing Woption under excellent visualization for the repair of difficult hernias with bony or muscular margins, such as lumbar, suprapubic and subcostal hernias. Several patients have hernias on or near lateral borders of the abdomen, making mesh fixation with tacks difficult. The robotic platform allows the surgeon to take precise bites of tissue to anchor the mesh repair.

Limitations of this robot-assisted technique are obvious. Large ventral hernias, as they approach the working ports

and camera, make this technique technically challenging for the robotic arms to be placed and to be able to work with the angulations needed or when the amount of redundant skin is large and removal of soft tissue is indicated.

Traditionally, LVHR involves three primary steps: 1) gaining safe access to the abdomen, 2) adhesiolysis, and 3) placement and fixation of a large overlapping sheet of tissue separating mesh. Technically speaking, this approach illustrates the four shortcomings of this surgical approach. Adhesiolysis is the Achilles heel of this procedure due to its technical difficulty, most notably in recurrent hernia, and previous mesh placement increasing the risk for iatrogenic enterotomies. This difficulty is accentuated by poor ergonomics and the demands of applying nonarticulating instruments high on the anterior abdominal wall. Second, bridging defects may predispose to migration or eventration of the mesh into the defect and seroma formation. Third, the requirement for circumferential tacks and multiple full-thickness transfascial sutures to adequately secure the intraperitoneal onlay mesh (IPOM) predispose to both acute and protracted pain (J ( Gastrointest Surg 2002;8:670-674; Am Surgg 2003;69:688691). Lastly, in a certain group of patients, leaving mesh in the intraperitoneal area may complicate future surgical intervention (World J Surgg 2003;31:423-429).

Robotic ventral hernia repair may resolve these shortcomings by allowing the operator to offer traditional open repair techniques through minimally invasive incisions.

Robotic repair of ventral hernias was first described in 2002 by Garth Ballantyne, MD (Surg Endoscc 2002;16:13891402). Improved visualization, tremor-free precision and superior ergonomics form the basis for the emergence of robotic techniques in the hernia space. continued on page 6

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jContinued from page 4

Preoperative Considerations Obtaining a thorough history and physical examination is mandatory to coordinate an operative plan. Specifically, comorbidities such as diabetes, obesity, smoking and collagen vascular disease may critically affect the operative plan.

A computed tomography scan of the abdomen and pelvis is critical to preoperative planning and remains the gold standard imaging test. This imaging modality can delineate the size and location of the hernia defect, the content of the hernia, sac, and possibly the position of previously placed mesh.

A complete medical history along with imaging offers the opportunity for surgeons to construct a risk–benefit ratio.

This scale can then be presented to the patient so he or she can make an informed decision about whether or not to proceed with surgery and what kind of repair is best for the specific hernia.

• Placement of retromuscular mesh with or without posterior component separation The individual technique is chosen based on location of the hernia defect, size of the defect and, perhaps most importantly, surgeon experience. Below is a detailed description of each technique.

Repair Techniques

Robotic Rives-Stoppa Repair With Bilateral Transversus Abdominis Release The retromuscular hernia repair as described by Rives is considered by many to be the standard by which all hernia repairs are judged. The posterior

Hernia repair techniques amenable to the robotic approach include: • IPOM bridge • IPOM after primary closure of the defect • Preperitoneal placement of mesh

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component separation technique allows for the closure of large hernia defects with wide prosthetic mesh overlap. These two techniques performed in tandem have traditionally been exclusive to open hernia repair (Surg Clin North Am 2008;88:10831100; Am J Surgg 2012;204:709-716; Plast Reconstr Surgg 1990;86:519-526; Chirurgie 1985;111:215-225).

The retromuscular repair as described

by Rives uses the natural myofascial planes of the abdominal wall while preserving the integrity of the subcutaneous tissue (Chirurgiee 1985;111:215-225).

In this technique, mesh is secured in the retrorectus position, sandwiched by closure of the anterior fascia above and by the posterior fascia below. With recurrence rates reported to be in the range of zero to 4%, many consider this technique of open ventral hernia repair as the gold standard for all hernia repairs (Surg Clin North Am 2008;88:1083-100; Am J Surg 2012;204:709-716). The limitation of the Rives-Stoppa repair is that the maximal transverse diameter of the mesh is confined to the lateral edge (linea semilunaris) of the rectus muscles.

The transversus abdominis muscle release, as described by Novitski et al, involves incision of the lateral posterior sheath, identification and division of the transversus abdominis, and dissection of the preperitoneal space ((Am Surg 2006;72:808-813). This modification allows for wide release and advancement of the posterior rectus sheath and peritoneum below the arcuate line, preservation of the neurovascular bundle serving the rectus abdominis, and wide lateral dissection to the level of the lateral border of the psoas muscle. In the setting of large incisional hernias, this technique allows for reconstruction of the linea alba, reapproximation of the rectus to the midline, placement of a large overlapping mesh unlimited by the confines of the linea semilunaris, and closure of the posterior sheath.

Although considered an effective and durable technique with low recurrence rates, trauma to the abdominal wall via open hernia repair is associated with a high incidence of wound complications, including mesh infections, which may lead to unacceptable patient morbidity ((J Gastrointest Surgg 2002;8:670-674; Am Surg 2003;69:688-691). Use of the da Vinci robot has enabled minimally invasive replication of this technique traditionally reserved for open repair.

Abdominal wall reconstruction by posterior component separation mandates dissection of individual layers of the abdominal wall intended to primarily close large hernia defects, create a large space for the placement of a reinforcing prosthetic mesh, and ultimately restore the anatomy and physiology of the abdominal wall. Therefore, a thorough

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

Figure 1. Patient positioning and trocar placement.

Figure 4. Incision of the lateral posterior sheath.

Figure 5. Division of the transversus abdominis muscle.

Figure 6. Preperitoneal dissection.

cranial-caudal dissection is based on the size of the defect, ensuring a minimum of 5 cm of overlap (Figure 2).

Transversus Abdominis Release The uniform retraction afforded by pneumoperitoneum allows dissection

within an avascular plane to the level of the linea semilunaris. The neurovascular

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continued on page 8

Figure 2. Posterior sheath incision.

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Figure 3. Anatomy of the posterior dissection. knowledge of the anatomy of the abdominal wall is critical to optimizing patient outcomes. Hernia repair by abdominal wall reconstruction and component separation should be regarded as the definitive repair for large hernias under tension due to the wide defects in the fascia.

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Patient Positioning, Trocar Placement and Docking For the majority of patients with large defects in the midline, supine positioning with the arms tucked is preferred, unless trocar access to the lateral abdomen is obscured. Trocars are placed in the lateral abdomen similar to conventional laparoscopic repair. Optical trocar technique, preferably in a location remote from previous surgical intervention, is used to gain initial access. An 8- to 12-mm trocar is placed in the lateral abdomen and then two 8-mm trocars follow on each side of this trocar (Figure 1).

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Essential Steps Posterior Sheath Incision The anterior abdominal wall is cleared of all adhesions to adequately define and size the hernia defect. The retromuscular space is accessed by incision and subsequent mobilization of the posterior sheath. Below the arcuate line, the peritoneum and transversalis fascia are mobilized in a similar fashion. The degree of

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

jContinued from page 7 bundle serving the rectus is exposed and preserved. An incision is made in the lateral posterior sheath of the upper third of the abdomen where the medial fibers of the transversus abdominis muscle are most prominent. The muscle is exposed and divided along the extent of posterior sheath and peritoneal dissection (Figures 3-6). This step allows entry and dissection into the preperitoneal space, resulting in wide release of both the posterior and anterior sheaths.

When sufficient posterior sheath release has been accomplished, mirror image trocars are placed on the

contralateral abdomen; the robot is undocked; and the patient is rotated 180 degrees and the robot is redocked. (This step is eliminated by the rotational capability of the da Vinci Xi.) The contralateral posterior sheath is then dissected and the steps above are repeated.

Closure of the Anterior Sheath, Mesh Placement, and Posterior Sheath Closure Closure of the anterior sheath is accomplished by using a 0 V-loc (Covidien) suture in a running fashion. The subcutaneous tissue and hernia sac are incorporated into the closure to obliterate the anterior dead space. This step restores the

linea alba and the rectus abdominis muscle to the anatomically and physiologically correct position (Figure 7).

The extent of dissection is measured in cranial-caudal and axial dimensions to choose an appropriately sized mesh.

Light or midweight polypropylene mesh is positioned by a single central transfascial suture in the retromuscular position.

Circumferential fixation is accomplished with absorbable tacks or suture (Figure 8).

The posterior sheath is then reapproximated using 0 V-loc long-term absorbable suture (Covidien). It is often helpful to incorporate a bit of mesh to elevate the

Figure 7. Closure of defect.

Figure 8. Placement of mesh after closure of defect.

Figure 9. Posterior sheath closure.

two leaves of the posterior sheath away from the intraabdominal viscera. The peritoneum is reapproximated below the arcuate line (Figure 9).

Drain Placement Secondary to pneumoperitoneum, the retromuscular space represents a large potential area for seroma formation. Trocars are withdrawn from the intraperitoneal cavity into the retrorectus space. In this position, adequate hemostasis can be confirmed and two 19 F drains are placed.

In summary, the technique of robotassisted laparoscopic incisional hernia repair with intracorporeal closure of the fascial defect and continuous circumferential suturing for mesh fixation is feasible, and may reduce postoperative pain by eliminating transfascial sutures. The component separation techniques done robotically may decrease the incidence of wound infections in this difficult group of patients.

Further evaluation is needed, and long-term data are lacking to assess the benefit to the patient, but early results are encouraging, especially if postoperative pain and wound infections compared with laparoscopic or open procedures.

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

Irrelevant Interrogations How the Quest for Patient Data Is Gathering More and More About Less and Less B Y S TEVEN S. K RON , MD

T

he day before I was to undergo a minor outpatient procedure, “Marie,” an employee of the surgical center, called me. The questions began and went on and on. As anyone who has ever been in that situation knows, they were intrusive and personal—the kinds of things only discussed with your doctor, not an anonymous stranger. So much for HIPAA. Following this experience, I began to pay closer attention to the data-gathering system in my own workplace, a hospitalbased endoscopy center where I am the primary anesthesia provider.

Once upon a time, patients were admitted to the hospital days before a procedure. The house staff, as well as the admitting physician, surgeon or endoscopist, examined them and wrote up their histories and physicals. Lab data, x-rays and other studies were performed and recorded. It was all available in a nonvirtual handwritten chart.

As the price of hospital beds accelerated to unsustainability, that system was discarded and replaced with outpatient procedures where possible, outpatient workup for all but the sickest patients and a new job description: “Marie, Collector of Information” (MCI), a secretary or an already overburdened nurse.

The flow of information from the MCI to the endoscopist, anesthesiologist or other physician involved with care is aided, abetted but unfortunately complicated by the partial introduction of electronic health records (EHRs) and the continued presence of a large pile of paper accompanying the patient.

If the MCI is able to contact the patient on the pre-procedure day, the patient’s historical information is collected and recorded in the EHR with the blanks filled in on admission. If the patient is unavailable, the collection of information begins in the cubicle before the procedure.

And what a collection process it is.

In addition to reasonable medical information, the patient is interrogated in depth about things that are irrelevant to the procedure. None of this is the fault of an MCI or the institution that is commanded to collect this information by bureaucrats working for state and federal governments and insurance companies.

Furthermore, in this era of supposed evidence-based medicine, no controlled studies definitively demonstrate the utility of these data.

Examples abound: MCI: “Do you smoke?”

Patient: “No.” MCI: “Did you ever smoke?”

Patient: “Yes.” MCI: “When did you quit?”

Patient: “35 years ago.”

MCI: “How much did you smoke 35

years ago?”

Patient: “I don’t remember.”

MCI: “You have to tell me something so I can fill in the blank on the computer.”

Patient: Blank stare.

Similar interrogations ensue about alcohol intake, religion, safety at home, measles, chickenpox and so on.

Then it’s my turn. Getting the information I need to provide a safe anesthetic can be challenging. I am mandated to not use the computer console in the patient’s

room while the nurse is signed on. I can sign out the nurse and sign myself in or go to a different screen and complete the sign-in process there. Both procedures take time and provide only limited information.

The papers on the patient’s bedside stand are more helpful. I used to rummage through them to locate the medication list but more recently simplifying my search, the nurses leave that list on the see INTERROGATION PAGE 10

Next stop: G GeneralSurgeryNews.com Ge eneralS u r g e r y N e w s . c o m Your Grand Central Station for all the latest new ws, opinions and analysis in surgery.

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Opinion INTERROGATION jContinued from page 9

anesthesia record. The patient’s medicines provide a convenient launchpad into his or her medical history that I supplement by asking appropriate questions. These emphatically do not include querying the patient’s preference for microbrews or a nice Chianti for his or her bimonthly alcohol consumption. Finally, we take the patient into the procedure room and do what he or she came for.

You might ask why all this is important; why does it matter?

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

There are a few answers. First of all, as noted above, much of this information is unnecessarily intrusive and personal and, in the endoscopy setting, has no real bearing on patient care. The patient may feel uncomfortable revealing information to someone other than his or her personal physician (although my opinion on this may well be wrong: A large younger population cohort raised on Oprah, Dr. Phil and naturally, the social media, appears willing, and even enthusiastic, to surrender their privacy to the world).

Second, like a misdirected romantic tweet or nude selfie, this information

lives forever in the cloud, where it may be hacked or may come back to haunt the patient in ways yet unimaginable.

Third, the data-collection process is cumbersome, time-consuming and frustrating for the collectors. As pointed out by one of my colleagues Alan Weintraub, MD, creating multiple parallel lines of information rather than one continuous one written by and available to all involved parties, makes for tremendous duplication of effort.

And finally, this process puts doctors and nurses in a double bind. On one hand, we are urged and coerced to

increase speed and efficiency; on the other hand, we are required to waste time collecting and documenting stacks of irrelevant interrogations.

While pondering this dilemma, the solution suddenly became obvious. I’ll contact the hospital and we’ll establish a committee! All the stakeholders—even the MCI—will be represented. We’ll have weekly meetings, think outside the box, consider robust solutions, eliminate silos, write minutes, have lunch and ...

—Dr. Kron is an anesthesiologist in — Hartford, Conn.

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Lapa r Tech oscopic niqu e Rep air: U s for He r ps a nd D nia own s

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

EMRs and Smart Technology: Vectors of Infection in a Modern World Disinfecting Your Wired World PETER J. PAPADAKOS, MD, FCCM, FAARC

O

ver the past five years, there has been an explosion in the use of electronic medical records (EMRs) and personal electronic devices (PEDs) by health care workers. Patient and visitor use of PEDs in the clinical setting is

popular and common. The recent Ebola crisis brought to light the shortcomings of control policies in modern health centers. As early as 2013, there were press reports of transmission of the virus via a cell phone in Uganda.1,2 However, few guidelines even address how shared computer keyboards and smart screens affect the spread of disease between health care workers and patients. The way we use such devices, without thinking, as part of our daily routine, could develop into an

ideal vector for such a deadly infection.

Studies already have reported that 5% to 21% of health care workers’ mobile phones provide a reservoir of bacteria known to cause infections,3,4 but if we look at any clinical setting, we see health care workers constantly entering information through shared keyboards and constantly using the touch screens of their PEDs without thinking that such practices can spread infection to themselves and others.

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I can picture a scenario in which individuals are treating a contagious patient in full gown, gloves and mask coming into contact with bodily fluids and using a PED, and then using that same PED to respond to a text without gloves a few moments after removing the protective gear. In a world that is wired to respond to every alert and message, even the besteducated health professional may not stop to think that a keypad or screen was not disinfected after treating the last patient.

Even in 2008, a microbiological analysis of 75 doctors’ mobile phones isolated a total of 90 bacterial pathogens5; and since this study was undertaken before the widespread use of smart screens and EMRs, the numbers can only have increased.

We must all be aware of this hidden vector of the spread of new, potentially deadly infections. A question to be asked in any debate on containing a virulent pathogen is the role of these new technologies that are touched by all, but cleaned by few. Thus, I believe regulatory agencies, hospitals and health care providers should address this important issue. We must also be aware that patients and their families and visitors also contaminate their PEDs and may also act as vectors by infecting large numbers of individuals who may share or use their PEDs. I recommend that health care workers and the population at large be educated with clear guidelines and advice on smart screen and PED etiquette and the proper cleaning and disinfecting of such devices. This recent Ebola experience may be a catalyst for such education.

Starting today, we must develop preventive strategies like routine decontamination of PEDs, smart screens and keyboards with proper disinfection agents.

Such agents should be part of our regular use of such devices, and manufacturers should push for their use. We should have a policy of leaving PEDs and clinical computers outside the room so as not to contaminate them. For decades, we have treated patients with virulent infections and did not bring the chart rack into the room and we did not write our notes with contaminated gloves, so why should we change that practice today?

—Dr. Papadakoss is director of critical — care medicine at the University of Rochester Medical Center, in Rochester, N.Y.

References 1. New York Daily News. August 27, 2014.

2. Huffington Post. t August 27, 2014.

3. J Hosp Infect. t 2009;71:295-300.

4. Clin Microbiol Infect. t 2011;17:830-835.

5. J Med Sci. 2008;8:73-76.

EXTENDED HERNIA COVERAGE

Heavy Lifting May Not Put Patients At Risk for Hernia Reoperation

February 2015

Americas Hernia Society Providing Value

B Y C HRISTINA F RANGG O U B Y B RENT D. M ATTHEWS , MD, FACS

P

atients who return to jobss involving heavy lifting or extended periods of walking or standing after in ngu uinal hernia repair do not appear too be at a higher risk for reoperation n, according to a study of more than 34,000 Danish men who underwent inguinal hernia repair between 1998 and 2008.

“We did not find any tendency toward a higher hazard ratio of reoperation among highly exposed men, not even highly exposed men who return to work early,” reported investigators Marie Vestergaard aaard d Vad, MD MD, and her colleagues in the Department of Occupational Medicine, Danish Ramazzini Centre, Aarhus University Hospital, in Aarhus, Denmark, in the online version of Hernia (2015 Jan 6. [Epub ahead of print]).

No relationship was found between total load lifted per day and the adjusted hazard ratio (HR) for reoperation, except for a marginally increased risk in the group lifting 500 to more than 1,000 kg per day (HR, 1.19; 95% confidence interval [CI], 1.00-1.141). Moreover, investigators found no association between reoperations and the daily frequency of lifting loads weighing more than 20 kg or for hours per day spent walking or standing.

IN THIS ISSUE

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S tudy Brings Spotlight Back on Quality-of-Life Outcomes

17

Scoring System Helps Predict SSOs After Open Ventral Hernia Repair

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Global Hernia Symposium to Explore Emerging Role of Robotics, Laparoscopy

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On the Spot With Colleen Hutchinson: Experts Discuss Controversial Topics in Hernia Repair

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adventure—my experience with laparoscopic hernia repair.

In those days, the institutional review board (IRB) was not an overwhelming concern. All we needed was a willing patient, a surgery center that would allow us to attempt these new procedures, and as I look back, some very crude laparoscopic instruments.

We tried some interesting and novel ways to fix the hernias (i.e., the plugs of Dr. Leornard Schultz), but then the techniques that Dr. Lloyd Nyhus instilled in me during my residency won out. In fact, I named my first repair the “double buttress repair” after Dr. Nyhus’s own open

ealth care is transitioning from supply-driven, organized around what surgeons do (volume-based), to patient-centered (valuebased), based on patient preferences, needs and vvalues. The ultimate goal is to reduce costs while improving patient care and outcomes.

In “The Strategy That Will Fix Health Care” in Harvard Business Review (October 2013), Michael Porter, the Bishop William Lawrence University Professor at Harvard Business School, and Thomas Lee, chief medical officer at Press Ganey, defined the six components of a strategic agenda for high-value health care delivery. These “interdependent and mutually reinforcing components are to: organize into integrated practice units; measure outcomes and cost for every patient; move to bundle payments for care cycles; integrate care delivery across separate facilities; expand excellent services across geography; and build an enabling information technology platform.”

Surgery societies, such as the Americas Hernia Society (AHS), are championing an increased role in this transition to patient-centered care. In fact, the theme of the 2014 annual meeting of the AHS, in Las Vegas, was “to improve patient care through continuous quality improvement that is patient-centered and surgeon focused.” The foundation for this concept was Dr. Bruce Ramshaw’s presidential mission of “learning together and improving clinical care” from 2013 to 2014. A transformative initiative of the AHS to foster patient-centered care was the development of the Americas Hernia Society Quality Collaborative (AHSQC; www.ahsqc.org).

Formed in 2013 under the leadership of surgeons Michael J. Rosen, MD, and Benjamin K. Poulose, MD, MPH, along with the AHS Board of Governors and

see LAP HERNIA page 26

see VALUE page 25

Other small mall studies s examined the effects cts of work activities on risk for recurrence and reoperation after inguinal hernia repair, but the findings have been inconsistent and inconclusive. This study, the latest in a series from this group of investigators, is the largest examination of this relationship.

Using register information, the investigators identified all men born in Denmark between 1938 and 1988 who had a first inguinal hernia repair between 1998 and 2008, were between 18 and 65 years old, and were active in the labor market at the time of surgery. The cohort was composed of 34,822 men.

The Danish Hernia Database provided information on see HEAVY LIFTING page 19

My 25 Years of Laparoscopic Hernia Repair B Y E DWARD L. F ELIX , MD

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his article presents the musings of an aging laparoscopic surgeon, and should be taken only as his personal memories of history and his own interpretation of the significance of those memories as they influence the future of inguinal hernia repair.

It seems like just yesterday, but it was 25 years ago that I called Dr. Robert Sewell, one of the many early adopters of laparoscopy who was willing to try anything with a scope, and asked, “Do you have any idea how we can fix an inguinal hernia using a laparoscope? “ He said he did.

I flew to Dallas, and thus began a 25-year

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Study Brings Spotlight Back on Quality-of-Life Hernia Outcomes B Y V ICTORIA S TERN

E

xperts continue to explore and debate the best method for repairing an inguinal hernia. To date, dozens of studies evaluating laparoscopic techniques have shown consistently compelling outcomes for total extraperitoneal (TEP) inguinal hernia repair, which highlight low rates of recurrence and complications (Surg Endosc 2011;25:2773-2843).

“Now that surgeons have completed the learning curve in laparoscopic inguinal hernia repair, it is time to reassess the most important outcome of repair: quality of life,” said lead study author Michael Ujiki, MD, a general surgeon in the Section of Minimally Invasive Surgery, Department of Surgery, NorthShore University HealthSystem, Evanston, Ill. In the current study, Dr. Ujiki and his colleagues assessed quality-of-life outcomes in the first year after patients underwent TEP (Surg Endosc 2014 Dec 6.

[Epub ahead of print]).

Four surgeons at NorthShore University HealthSystem performed more than 1,000 TEP inguinal hernia repairs between June 2009 and February 2014. The analysis included 301 patients with 388 hernias evaluated preoperatively (43.8% of patients), and at three weeks (56%), six months (20%) and one year (40%) postoperatively using the Short Form-36 Health Survey Version 2 (SF-36v2), which ranges from 0 (worst health) to 100 (best health) and the Carolinas Comfort Scale, developed explicitly to evaluate quality of life after hernia repair.

The meshes of choice were macroporous polyester mesh (Parietex Anatomical, Covidien), used in 65% of cases, and macroporous polypropylene mesh (Physiomesh, Ethicon), used in 31% of cases. Mean patient

age was 56.4 years and mean body mass index was 26.1±3.7 kg/m2.

Of the 301 patients, 23% (69) encountered early complications, including urinary retention (8%), seroma (8.3%) and hematoma (4.3%), but only 2.1% of patients (6) had recurrences. Patients, on average, returned to their normal activities and to work 5.5 days (±4.4) and 5.6 days (±3.9) after surgery, respectively. Physical functioning also improved before surgery and six months after surgery (84.0±22.4 to 92.8±14.7; P=0.05).

P

‘TEP certainly has a long learning curve, so this study helps show that we must teach the next generation this technique so that it becomes standard.’

—Michael Ujiki, MD One year after surgery, TEP patients generally reported significant improvements in physical health, social functioning and pain. Although, on average, patients had worse pain at three weeks (67.4±23.3; P P=0.005), they got progressively better at six months (82.9±16.1; P=0.14) P and one year after surgery (88.0±23.3; P P=0.49). At one year, 13% of patients reported worse pain compared with baseline using the SF-36v2 scale, but when the authors switched to the hernia-specific Carolinas Comfort Scale, the number dropped to less than 2%. Using this surgery-specific scale, the authors found that after one year, 91% of patients reported no sensation of mesh, 95% described no limitations in movement and 92% had no pain, whereas only 0.4% of patients reported severe pain or limited mobility.

Patients also reported better emotional well-being and social functioning one year after surgery, although the

improvement was only statistically significant for social functioning (92.9 at baseline vs. 87.4 at one year; P=0.02).

P Scores for general health and energy and fatigue, however, were not significantly different throughout the year compared with baseline reports.

Dr. Ujiki concluded that overall TEP inguinal hernia repair is associated with low recurrence and morbidity as well as improvements in several quality-of-life parameters.

“We were happy to see that less than 2% of patients reported any bothersome groin symptoms at a year,” Dr. Ujiki said.

Commenting on the study, Guy Voeller, MD, professor of surgery at the University of Tennessee Health Science Center, in Memphis, who was not involved in the research, said, “What this study does is continue to show that TEP is a good operation. When TEP is done properly by expert surgeons, patients do well.”

To this end, Dr. Ujiki noted that the four surgeons in the study had ample experience in TEP, which could help explain the good outcomes. “TEP certainly has a long learning curve, so this study helps show that we must teach the next generation this technique so that it becomes standard,” Dr. Ujiki said.

Although the study results did not surprise Drs. Ujiki or Voeller, Dr. Voeller noted that these kinds of studies evaluating quality of life after hernia repair will become increasingly relevant in the emerging health care landscape.

“With the rollout of Obamacare, it’s getting more and more important to show that a surgical procedure has value in terms of quality and cost,” Dr. Voeller said.

“Evaluating cost wasn’t so important a decade ago but, in the near future, it will be. Surgeons will need to show that a costly technology or more expensive procedure gives true value to the patient for the cost.”

Experts Debate Value of Randomized Controlled Trials for Hernia Repair B Y V ICTORIA S TERN

R

andomized controlled trials have long been regarded as the gold standard for evaluating and comparing clinical interventions. The highest level of evidence to test the efficacy of a new treatment is given to systematic reviews of RCTs, summarized by meta-analyses (BMJJ 1996;312:71; Herniaa 2012;16:503).

Although most experts would concur that RCTs and meta-analyses represent the highest level of evidence for proving the efficacy of a treatment, some have questioned whether the findings of these studies always provide generalizable or reliable evidence (Lancett 2005;365:82-93).

Now, an article from surgeons in the United States, Canada and Germany challenges the supremacy of RCTs and metaanalyses in relation to hernia repair (Int J Clin Medd 2014;5:778-789). The analysis examines nine main limitations of RCTs and meta-analyses for hernia treatments.

“In my own work, I have come to learn that it is not possible to prove the superiority of one treatment or mesh in a clinical trial, which was the impetus for the current exploration,” said study author Uwe Klinge, MD, a surgeon in the Department of General, Visceral and Transplant Surgery, University Hospital RWTH Aachen, in Aachen, Germany. “Overall, I have found that there are huge variations across RCTs in hernia repair, and therefore many meta-analyses, in principle, are not able to analyze differences, not least due to the limited power of most studies investigating effects with an incidence of a few percent.”

Guy Voeller, MD, professor of surgery at the University of Tennessee Health Science Center, in Memphis, who was not involved in the research, agreed that “the reality for patients and surgeons is much more complex than an RCT on hernia surgery can reveal.”

Robert J. Fitzgibbons, MD, Harry E. Stuckenhoff Professor of Surgery at

Creighton University School of Medicine, Omaha, Neb., who also was not involved in the research, said, “I think that, overall, the article makes valid points that there are serious limitations to RCTs and that we have to be careful how we interpret them, but RCTs remain a very valuable tool for surgeons.”

Because treatment guidelines originate from RCTs, it is of utmost importance to design the highest-caliber RCTs, said study co-author Robert Bendavid, MD, FACS, FRCS(C), a surgeon at the Shouldice Hospital in Toronto, Ontario, Canada.

The authors began by discussing issues with meta-analyses of hernia repair, highlighting that these studies often find nonsignificant differences or similar results.

To demonstrate this point, they performed a PubMed search for “meta-analysis” and “hernia” and found 35 articles from 2012 on abdominal wall hernias, 25 of which (71%) could not confirm significant differences for a range of outcome

parameters. Only seven of the meta-analyses were able to confirm significant differences, but these results often conflicted from study to study.

The specific studies included in a metaanalysis can also skew the results of a trial.

For example, one meta-analysis revealed that transabdominal preperitoneal (or TAPP) and total extraperitoneal (or TEP) laparoscopic techniques resulted in a significantly higher rate of recurrence than the Lichtenstein technique (Surg Endosc 2005;19:188-199), but Dr. Klinge and his colleagues found that this higher recurrence rate vanished when they excluded a single RCT that contributed 76% of all recurrences.

“I would never remove a certain study, but the example shows the disproportional impact that a single study can have on the mean results,” Dr. Klinge said.

In another limitation, the authors addressed flawed study designs and how that can affect the results or interpretation of results. In a retrospective study,

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

Dr. Klinge explored a range of factors that could influence the development of an incisional hernia in 2,983 patients who underwent a laparotomy (Der Chirurg 2002;73:474-480). After analyzing the data, he found that patients operated on by the most experienced surgeons had the greatest risk for an incisional hernia, whereas those treated by residents had the lowest risk.

“This made no sense,” Dr. Klinge said.

“When we looked more closely, we found that the residents treated patients with fewer risks and that the most experienced surgeons had to deal with patients with the greatest risks.” In other words, the relationship between surgeon experience and incisional hernia risk was more complex than the numbers alone could reveal.

But the study design made it impossible to identify the most important variable or to weigh each variable’s impact on patient outcomes and risk, Dr. Klinge said.

The majority of the limitations in the article discussed statistical modeling in RCTs. The authors stated, for example, that patients are often deemed normal if 95% of their peers share a certain characteristic, and the cohort of standard patients decreases by about 5% with each new variable included in the analysis. In other words, if a study with 1,000 patients included 10 variables, the cohort of standard patients would be reduced to 599 (1,000 × [0.9510]). Thus, the authors argue, as the number of study variables increases, so too does the number of subgroups, creating too many subgroups with too few patients to achieve meaningful results.

Ralf-Dieter Hilgers, PhD, director of the Department of Medical Statistics at RWTH Aachen University, in Germany, and a reviewer for the journal Hernia, agreed that poor statistical analysis or study design can lead to errors in interpretation and result in invalid conclusions, and that RCTs in surgery should follow a more rigorous methodological approach with regard to design and analysis, but he found many of the authors’ assumptions and statistical analyses to be flawed.

For instance, the statement that “often a value is accepted as ‘normal’ when 95% of the patients show this characteristic” is not considered a standard assumption in clinical trials and the corresponding calculation for the normal patient population is predicated on the idea that each variable is independent, which is not the case, Dr. Hilgers said. Subgroup analyses in RCTs are valid only if they are preplanned, and multiple subgroup analysis should be avoided.

Dr. Hilgers also pointed out that metaanalyses are descriptive in nature, and researchers should not, in general, be excluding studies with different results because there are statistical models that account for variations and detect heterogeneity between studies.

One of the most glaring issues, however, is that the authors seem confused about the aim of randomization. The purpose, as the authors assume, is not to provide a random sampling from a population or to compare all patient subgroups. Furthermore, an RCT is not able to answer all questions in all possible subgroups.

“This is a misunderstanding of the idea of RCTs, which I call splitting, because you end up splitting the sample into all possible samples and then ask if the treatment works in every [possible] subgroup,” Dr. Hilgers said. “This scenario is not something an RCT can

‘I think trying to show the best repair or mesh is a waste of time. It is most important to show that the repair you do has excellent results, no matter which you do.’

—Guy Voeller, MD uncover. In fact, such an analysis would end up revealing personalized therapy, which is not something we have a

method to prove at the moment.”

Instead, Dr. Hilgers explained, the objective of randomization “is to balance observable and unobservable variables between treatment and control groups, so that we have matching groups of patients and can estimate a difference in the treatment effect based on the treatment alone.”

Dr. Klinge agreed with this assessment, but noted that “we need to do subgroup analysis to identify patients at risk, which is why I think RCTs are too limited to answer many of our questions.” Ultimately, Dr. Klinge said, “we do want to be able see HERNIA TRIALS page 16

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HERNIA TRIALS

jContinued from page 15 to tailor and personalize treatments to individual patients.”

Although Benjamin K. Poulose, MD, MPH, associate professor of general surgery and director of the Vanderbilt Hernia Center, Nashville, Tenn., shares concerns about the reasoning behind the limitations, he thinks the article brings up an important general concept that RCTs are difficult to perform in the hernia field. Part of the difficulty in studying hernia repair, he noted, is that hernia disease itself is so

heterogeneous and surgeons have so many methods and tools to treat a hernia.

“I once calculated that there are about 16,000 ways of performing an incisional hernia repair, which is an issue that leads to a lot of variation and, likely, suboptimal care,” Dr. Poulose said.

According to Dr. Voeller, another factor to consider is that everyone responds differently to different procedures or materials. “Take mesh, for instance,” Dr. Voeller said. “A surgeon can put the same piece of mesh in five different people and they may all have different outcomes, an important nuance that cannot be captured

by an RCT. That is why I think trying to show the best repair or mesh is a waste of time. It is most important to show that the repair you do has excellent results, no matter which you do.”

Given the complexity of the hernia surgery landscape, the authors proposed that a hernia registry may be the best way to evaluate risk factors for a variety of repair techniques and patients. Hernia registries would permit surgeons to document a range of variables known to influence patient outcomes, which could lead to more continuous quality improvement.

Several hernia registries have already

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been established in Sweden, Denmark and Germany, and in the United States with the Americas Hernia Society Quality Collaborative (AHSQC). In Germany, the hernia registry is compiling a database of 100,000 hernia repairs annually.

“This registry will allow us to compare trends in hundreds of thousands of patients,” said study co-author Andreas Koch, MD, a surgeon in Cottbus, and a member of the scientific board at the Institute for Quality Assurance in Surgical Medicine at the University Magdeburg, in Magdeburg, both in Germany. “If we follow up with even 50% of patients over the years, we will have an incredible database of information. We can then use registries to help us ask the right questions, which could be answered by RCTs.” Dr. Hilgers agreed that this is a potential use of registries. “Registries are good for generating hypotheses or seeing what happens in practice, and RCTs bring the proof that a treatment should go [into] practice,” Dr. Hilgers said. However, the register data are prone to bias depending, for example, on the operations included and the patient populations selected.

Dr. Fitzgibbons believed that registries are important, but are only as good as the veracity of the data collected and the structure of the registry.

“Registries commonly depend upon the busy surgeon to input the data, which can be problematic, especially with computer-based entry forms with hard stops that force the best guess when the data is not immediately available, such as the patient’s ASA [American Society of Anesthesiologists] score. Ideally, a third party not directly involved with the care of the patient collects and enters the data, as is done with the American College of Surgeons’ National Surgical Quality Improvement Program, which provides outcome data,” Dr. Fitzgibbons said.

Dr. Bendavid agreed, noting that in registries, criteria are omitted, excluded or simply unavailable, and therefore data need to be as complete as possible in order to reach meaningful conclusions.

A hernia registry may be particularly important in the United States because the health care system is not designed for surgeons to follow patients on a long-term basis or to show quality improvements.

“That can be made possible with a registry,” said Dr. Poulose, who co-founded the AHSQC with his colleague Michael Rosen, MD. However, Dr. Poulose noted, registries are a challenge to manage. “Designing, executing and running the operations of a national registry effort is very hard and time-consuming work. It takes commitment from the registry sponsors, surgeons, surgical teams and patients,” he said. “But when done well, we can get clinically meaningful information that has the ability to change practice.”

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Scoring System Helps Predict SSOs After Open Ventral Hernia Repair B Y V ICTORIA S TERN

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espite efforts to predict and track complications after open ventral hernia repair, surgical site occurrences (SSO) remain common.

To better understand patient outcomes, surgeons at the University of Pennsylvania and Yale School of Medicine developed and attempted to validate a new risk model for predicting SSOs after open ventral hernia repair (Hernia 2014 Dec 4. [Epub ahead of print]).

“The authors have developed a scoring system that may be very useful,” said Robert J. Fitzgibbons, MD, Harry E. Stuckenhoff Professor of Surgery at Creighton University School of Medicine, Omaha, Neb., who was not involved in the investigation. “The scoring system seems to be based on parameters that all surgeons would agree are important in ventral hernia surgery. The hard part, as with any risk calculation system, will be using it to change treatment strategies for patients, such as actually denying a patient surgery because of an unfavorable score.”

The new risk model, called the Hernia Wound Risk Assessment Tool (HW-RAT), builds on previous scoring systems, most notably the widely used Ventral Hernia Working Group (VHWG) model and the recently developed Ventral Hernia Risk Score (VHRS). In a previous analysis assessing existing risk models, the VHRS had better predictive value than the VHWG (J ( Am Coll

Surgg 2013;217:974-982), but had limited generalizability because it only included direct patient data from a single institution.

To generate a risk model reflecting a broader patient population, John Fischer, MD, Jason Wink, MD, and Stephen Kovach, MD, who are surgeons in the Division of Plastic Surgery, Department of Surgery, Perelman School of Medicine at the Hospital of the University of Pennsylvania, in Philadelphia, collected patient outcomes after open ventral hernia repair from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database between 2005 and 2011. The ACS-NSQIP captures 30-day outcomes from thousands of patients at multiple institutions across the United States.

A total of 60,187 patients met the current study’s inclusion criteria. Of those, 6.2% (3,732 patients) had an SSO. The rate of SSOs was highest in dirty infected wounds (19.9%), contaminated wounds (18.3%) and component separation (15.8%). Other factors associated with SSO risk included higher body mass index, partially or totally impaired functional status, and smoking.

The authors conducted a multivariate logistic regression analysis of the risk factors associated with SSOs to calculate their relative risk scores, and then stratified patients into four main groups: mild (HW-RAT 1), intermediate (HW-RAT 2), moderate (HW-RAT 3) and severe risk (HW-RAT 4-6). The factors associated with the greatest SSO risk included operative time

greater than 118 minutes (6) and between 71 and 117 minutes (4), dirty or infected wounds (5) and wound contamination (4). Moderate risk factors included class III obesity, component separation, dependent functional status and inpatient hernia surgery; intermediate risk factors included smoking, clean-contaminated wound, low albumin, age younger than 45 years and operative time between 43 and 71 minutes; and mild risk factors were diabetes, chronic obstructive pulmonary disease, class I obesity, age 45 to 64 years and intraabdominal procedure.

“Overall, we found two main risk categories contributed to SSOs—patient risk factors and operative risk factors,” Dr. Fischer said. “Understanding these factors can inform the operative decision process for surgeons and improve preoperative risk counseling, helping surgeons give patients more realistic expectations for their procedure.”

To test the validity of the model, Drs. Fischer and Wink and their colleagues assigned patients to specific HW-RAT risk groups and compared the accuracy of these designations. The model could reliably discriminate between patients with mild to severe SSO risk after open ventral hernia repair (P<0.01).

Finally, the researchers compared the HW-RAT with three existing models—VHWG, VHRS and National Nosocomial Infection Index—and found that the HWRAT could better predict SSO risk after open ventral hernia repair. see SURGICAL SITE page 25

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

Global Hernia Symposium To Explore Role of Robotics, Laparoscopy B Y C HRISTINA F RANGOU

I

n late March 2015, the International Hernia Collaboration (IHC) will host a first-of-its-kind surgical conference that will demonstrate and discuss robotic, laparoscopic and open hernia repairs.

“This is the first time our group will hold a focused consensus conference,” said organizer Brian P. Jacob, MD, associate clinical professor of surgery at the

Icahn School of Medicine at Mount Sinai in New York City, who is also a partner at the Laparoscopic Surgical Center of New York and founder of the IHC. “While obtaining CME, as part of the symposium, the audience will witness what a live robotic TAPP [transabdominal preperitoneal] repair looks like and compare it to a simultaneously performed laparoscopic TAPP repair,” he said. The symposium will also feature a live robotic incisional hernia repair by Alfredo

Carbonell, MD, from Greenville, South Carolina.

Social media, especially a platform like Facebook, when used appropriately, is helping to revolutionize the way doctors educate, colloborate and disseminate medical and surgical knowledge globally, according to Dr. Jacob. The idea for the First Annual Global Symposium on Robotic-Assisted and Minimally Invasive Hernia Repair grew out of discussions on the private Facebook group

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called the International Hernia Collaboration, currently made up of 930 vetted members from 62 different countries.

Surgeons commenting on the site frequently asked questions about robotic surgery and debated its merits versus laparoscopic and open surgery.

“When we realized that robotic surgeons were starting to embrace hernia and the passionate debates that were occurring on the site, we thought this symposium would be a perfect forum where hernia experts and robotic experts could come together and try to come to a consensus on where and when the robot is most appropriate in the world of hernia,” Dr. Jacob said.

“The IHC has shown that surgeons can successfully use social media in a professional manner in an effort to improve the quality of the care we provide, and to be able to provide an optimized treatment plan for our patients,” he said. “Most users check the site multiple times daily and continue to find it very valuable.”

Comments made on the page are accessible only to group members and are continuously audited to keep them HIPAA compliant.

“It is imperative that we examine which aspects of this emerging robotic technology are truly improving patient outcomes,” Dr. Jacob said.

The New York meeting will feature 30 faculty members and have real-time feeds of live operations performed in Brazil, Colombia and at centers throughout the United States, including hospitals in New York City, Cleveland and South Carolina.

The codirector of the course is Dana Telem, MD, from Stonybrook, N.Y., and the scientific committee will be led by Michael Rosen, MD, the director of the Hernia Center at the Cleveland Clinic, in Ohio, and president-elect of the Americas Hernia Society. Conrad Ballecer, MD, from Glendale, Arizona is assisting Dr. Rosen with the abstract selection.

One of the key issues that have emerged in the conversations is how the financing of health care systems in different countries affects surgical decision making, Dr. Jacob said. For example, surgeons in Israel have said they cannot easily order magnetic resonance imaging tests for hernia patients. In parts of Brazil, surgeons in some hospitals have easier access to the robot for hernia repair, but in Australia and India, for example, the robot is still off limits to most general surgeons because of costs, he said.

“The world is very, very diverse, and this becomes quite apparent when we are connected and collaborating online,” Dr. Jacob noted. Costs of using the robot will be a major focus at the symposium.

Jorge Daes, MD, director of minimally

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

HEAVY LIFTING

jContinued from page 13 repairs and reoperations, and investigators used occupational codes and a job exposure matrix based on expert ratings to estimate total load lifted per day, frequency of heavy lifting, and hours per day spent walking and standing.

The study showed that postoperative sickness absence was associated with increased mechanical exposure at work. In turn, prolonged postoperative absence from work was associated with an increased likelihood of reoperation. However, investigators said the prolonged absence from work was “not an intermediate step between high exposures and reoperations,” meaning the absence from work could not be explained by exposure-related complications that led to reoperation.

“Occupational mechanical exposures may be a risk factor of developing indirect (lateral) inguinal hernia, but it is not a risk factor of reoperation,” Dr. Vad said in an email.

Guy Voeller, MD, professor of surgery at the University of Tennessee Health Science Center, Memphis, said it is difficult to draw any conclusions from the study. Hernia recurrences are caused by multiple factors, he noted, and the design of the study made it difficult to evaluate causes of recurrence.

“In my mind, hernia recurrence wasn’t actually quantified, rather reoperations.

In regard to actual hernia recurrence, I think postoperative lifting is probably a minor reason for recurrence and more important factors exist that could lead to recurrence, like surgical technique, patient [body mass index], size of hernia at index operation, smoking, diabetes mellitus and other comorbidities that were not factored into this analysis.”

Dr. Vad’s team has conducted a series of studies looking at the contentious issue of whether heavy lifting increases risk for inguinal hernia. In 2012, they published a systematic review that found no evidence that occasional heavy lifting, repeated occupational strain or a single strenuous lifting episode resulted

invasive surgery, Clinica Bautista in Barranquilla, Colombia, posts every day and often broadcasts live surgery to IHC members. He said the IHC facilitates quick sharing of knowledge, technique, ethics and philosophy among a divergent group of surgeons “to obtain our main objective: to improve the quality of life of our patients.”

The Hernia Symposium will be held March 27 and 28 in New York City. Full details on the meeting can be found at www.herniasymposium.com.

in a groin hernia (Scand J Work Environ Health 2013;39:5-26), a finding that has considerable bearing on workers’ compensation and other medicolegal issues, explained Robert J. Fitzgibbons Jr., MD, Harry E. Stuckenhoff Professor of Surgery at Creighton University School of Medicine, in Omaha, and a co-editor of Hernia.

Soon after, the researchers conducted a population-based cohort study of nearly 1.5 million patients with inguinal hernias that showed that first-time inguinal hernia repairs for indirect inguinal hernias, but not direct hernias, were related

‘The topic remains controversial, especially considering the fact that weightlifters or obese patients do not seem to have an excessive incidence of inguinal hernias.’

—Robert J. Fitzgibbons Jr., MD

to frequent heavy lifting and prolonged standing or walking at work (Occup Environ Medd 2012;69:802-809).

“The topic remains controversial, especially considering the fact that weightlifters or obese patients do not seem to have an excessive incidence of inguinal hernias,” Dr. Fitzgibbons said.

Current Danish and European guidelines recommend immediate return to work by patients after uncomplicated surgery unless restricted by pain. The investigators said their findings contribute to the “evidence for the safety of this advice.”

Visit the Intuitive Surgical booth at these upcoming events 1st Annual Symposium on Robotic Assisted and MIS Hernia Repair • Mar 27-28 • NYC SAGES Annual Meeting • Nashville, TN World Conference on Abdominal Wall Hernia Surgery • Milan, Italy

AND DISCOVER WHY MORE SURGEONS ARE ADOPTING DA VINCI FOR HERNIA REPAIR Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Examples of serious or life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to, one or more of the following: injury to tissues/organs, bleeding, infection and internal scarring that can cause long-lasting dysfunction/pain. Individual surgical results may vary. Contraindications applicable to the use of conventional endoscopic instruments also apply to the use of all da Vinci instruments. Be sure to read and understand all information in the applicable user manuals, including full cautions and warnings, before using da Vinci products. Failure to properly follow all instructions may lead to injury and result in improper functioning of the device. Unless otherwise noted, products featured are available for commercial distribution in the U.S. For availability outside the US, please check with your local representative or distributor. Physicians should review all available information. Clinical studies are available through the National Library of Medicine at www.ncbi.nlm.nih.gov/pubmed. For Important Safety Information, indications for use, risks, full cautions and warnings, please also refer to www.davincisurgery.com/safety and www.intuitivesurgical.com. Spontaneous opinions expressed during live presentations by individual doctors or patients belong to those individuals. These opinions are not necessarily shared by Intuitive Surgical, Inc. © 2015 Intuitive Surgical, Inc. All rights reserved. PN 1017602 Rev A 1/15

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On the

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

{Spot} With Colleen Hutchinson The Art of Herniology 2015 Participants Gina L. Adrales, MD, MPH, FACS, is associate professor; co-director, surgery clerkship minimally invasive surgery and bariatric and metabolic surgery; associate director, MIS fellowship, Geisel School of Medicine, Dartmouth, N.H.; director, Hernia Surgery Center, Dartmouth-Hitchcock, Lebanon, N.H. Disclosures: None.

B. Todd Heniford, MD, is chief, Division of Gastrointestinal & Minimally Invasive Surgery and professor of surgery, Carolinas Medical Center; director, Carolinas Hernia Center, Charlotte, N.C. Disclosures: Research Grant: Synovis and W.L. Gore; Education: Bard, Ethicon, LifeCell and W.L. Gore.

Karl A. LeBlanc, MD, MBA, FACS, is associate medical director at Our Lady of the Lake Physician Group; clinical professor of surgery at Louisiana State University and director and program chair of Fellowship Program, Minimally Invasive Surgery Institute, Baton Rouge, La. Disclosures: Speakers’ bureaus: Davol, Insightra Medical, Intuitive Surgical and W.L. Gore. Has options to Insightra and shares in Via Surgical.

Dmitry Oleynikov, MD, is Joseph and Richard Still Endowed Professor of Surgery; chief, Gastrointestinal, Minimally Invasive and Bariatric Surgery; director, Center for Advanced Surgical Technology, University of Nebraska Medical Center, Omaha.

Disclosures: Virtual Incision Corp stockholder.

Aurora D. Pryor, MD, is professor of surgery and vice chair for clinical affairs; chief, Bariatric, Foregut and Advanced GI Surgery; director, Bariatric and Metabolic Weight Loss Center, Department of Surgery, Stony Brook University School of Medicine, Stony Brook, N.Y. Disclosures: Freehold Medical (consultant) and W.L. Gore (honoraria for speaking).

Michael G. Sarr, MD, FACS, is the J.C. Masson Professor of Surgery and vice chair of research in the Department of Surgery, Mayo Clinic, Rochester, Minn.

Disclosures: None.

Guy R. Voeller, MD, is professor of surgery, University of Tennessee Health Science Center, Memphis.

Disclosures: None.

The meeting season is once again upon us, and lo and behold, critical hernia debate still exists. I would like to thank all of the contributors, and Guy Voeller, MD, in particular, for again helping with this column. This Part 1 “Art of Herniology” On the Spott hones in on usage—the use of the robot in hernia repair; the use of mesh in hernia repair; and the use of tacks, sutures and fibrin glue for inguinal hernia repair.

The participants’ knowledge of current and coming data, as well as their experience, provide invaluable insights here and in the Gut Reaction table on page 22. Let us know your thoughts by visiting the column online and commenting.

{

Part 1 of 2

Part 2 of this hernia-themed column will appear later this year, and will tackle what the surgeon should disclose to patients with regard to new mesh or techniques, complex abdominal wall reconstruction done by plastic surgeons, and something new for On the Spot—a t case presentation in which participants debate best treatment options.

As always, feel free to email me at colleen@ cmhadvisors.com with any ideas for debate in hernia and other areas of general surgery. Thanks for reading!

—Colleen Hutchinson

Statement: The use of the robot for ventral hernia repair is a great technological step in hernia repair.

Dr. Voeller: Disagree at present.

I definitely think it is a step in hernia repair, but I don’t know whether it is a step forward or a step backward. Time will tell. As the next parts of Obamacare kick in, money for high-tech devices is going to be harder to come by. Small hospitals are closing and large hospitals are struggling due to money issues. It is no longer enough to say we have this nice shiny, high-tech gadget. Now we must show value in surgery, and the two components of that are quality and cost. At present, there are no level 1 data to support value in the robot for hernia repair, and quality is unknown.

Dr. Pryor: On the fence.

I think robotics can make surgery easier on the surgeon, but not necessarily the patient. I am not sure for most hernias that the added costs of robotic repair are justified.

Dr. Oleynikov: Disagree.

There are currently no data to support that robotic hernia repair is in any way superior to current laparoscopic or even open techniques.

Dr. LeBlanc: Agree, to an extent.

Clearly my opinion on this subject has changed over the past few years. The robot allows us to do things, such as closure of the fascial defect, much more easily than we can with the traditional laparoscopic approach. It appears, anecdotally, that there is less pain when the mesh is sutured in rather than using transfascial sutures and tacks.

One important advance is the fact that we can do complex abdominal wall reconstruction that

mimics the open approach with the assistance of the robot. I believe we need more data, but at least currently, this appears favorable and with no increased cost (based on my own current data).

Dr. Adrales: Strongly disagree.

There is currently no evidence to support its use in ventral hernia repair. Our health care system is in crisis. Surgeons need to be good stewards of expensive technology and consider the value, or lack thereof, that such technology provides to the patient. Think of how many health problems could be addressed with the money spent on one robot.

Dr. Heniford: Disagree.

At the moment. The operation performed robotically takes longer and would be expected to be more expensive, but as of yet, extensive financial data are not available. If robotics improves outcomes in place of financial concerns by reducing downstream costs, such as decreasing complications or reoperation, or significantly improves other measureable factors, such as quality of life, then my answer might be upgraded to “maybe.” Robotics would need to show that it offers advantages to open and traditional laparoscopic hernia repair. (It is so interesting that I now say “traditional laparoscopic” repair. Have we come that far?!)

Dr. Sarr: Disagree.

Why would one need a robot to do this? Oh, come on. A robot?

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

{

Statement: Use of biologic mesh for hernia repair is a waste of money.

Dr. LeBlanc: Disagree.

The use of any biologic must be predicated on the correct usage of that material. There are situations that we cannot or should not use a synthetic product. In these scenarios, a biologic mesh allows the surgeon the ability to treat the hernia. These situations include associated bowel resection or in the face of an associated infection. However, it is important to clear up gross contamination before the use of a collagen-based material.

exception in my practice today is for hiatal hernia repair.

Dr. Heniford: Disagree.

In at-risk operations, the use of biologic mesh is appropriate. The cost of a mesh infection in a study that one of our fellows, Paul Colavita, MD, presented at the American College of Surgeons [Clinical Congress] demonstrated that over a year, the cost of a synthetic mesh infection was nearly $110,000.

Indeed, when we think we have salvaged a mesh from infection, the infection frequently recurs if long-term follow-up is

performed due to bacterial biofilm formation. As well, when one considers the chance of a lightweight synthetic failure in long-term follow-up in clean cases, its recurrence mimics that of biologic.

{

Statement: Tacks or sutures for inguinal hernia should be the preferred use over fibrin glue.

Dr. Heniford:: Agree.

In a long-term study via the International Hernia Mesh Registry, the use of glue versus tacks and sutures resulted in

21

a better quality of life at one month, and was equal at six months, but by one- and two-year follow-up, the recurrence rate was higher and the glue patients were twice as likely to have negative qualityof-life scores. The average follow-up in this study where the patients reported their quality-of-life outcomes independently was excellent.

Dr. Pryor: On the fence.

There are some good early data about using glue, although I still prefer to use absorbable tacks in my practice. see HERNIOLOGY PAGE 22

Dr. Adrales: On the fence.

In most cases, it is not needed and it is extremely expensive. It is unpredictable in terms of individual patient response other than the eventration or hernia recurrence, which is certain after a bridging biologic mesh repair. I have turned to bioabsorbable mesh or sometimes biologic mesh reinforcement for midline fascial closure in contaminated or clean-contaminated fields, such as treating chronic mesh infection that warrants mesh removal and recurrent hernia repair.

Dr. Voeller: Agree.

Introducing the only antibacterial-coated biologic graft *

I was a naysayer on biologic mesh from the beginning and rarely used it, and the data show I was correct. It never made sense to me that you would expect a hernia-former to populate an acellular matrix with cells that were going to secrete high-quality collagen. Research

by Yuri Novitsky, MD, and others have proven this does not occur. When we get back to our value equation, the cost of the biologic mesh is certainly prohibitive.

Dr. Sarr: Disagree.

But biologics should be used in specific situations where a permanent prosthetic is contraindicated for the “hernia-former.”

I personally do not believe that biologics are appropriate as a definitive repair.

XENMATRIX™ AB Surgical Graft

Protection when and where it’s needed. *It’s the first biologic graft for ventral hernia repair demonstrated to prevent colonization of MRSA and E. coli.

Protect the graft. Protect the repair.

Dr. Oleynikov: On the fence.

We have always had unrealistic expectations of what biologic mesh can do. It was never going to be the panacea of hernia repair in an infected field as a bridge. Used in select cases where other meshes may not be appropriate, biologics still have a role—albeit a diminishing one.

Dr. Pryor: Agree.

I think biologics have not demonstrated benefit long term, given the high frequency of failure. We also are showing good results with lightweight mesh even with some contamination. The one

Bard, Davol, and XenMatrix are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners. © Copyright 2014, C. R. Bard, Inc. All rights reserved.

DAV/XNAB/0814/0018

Indications: Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization in the device. The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.

Contraindications: 1. XENMATRIX™ AB Surgical Graft should not be used on patients with known sensitivity to porcine products.

2. Do not use in patients with allergy, history of allergy or hypersensitivity to tetracyclines or rifamycins or other components in the device.

3. Do not use in pregnant or nursing women.

4. The contraindications, warnings and precautions regarding the use of the antimicrobial agents Rifampin (a derivative of rifamycinB) and Minocycline (a derivative of tetracycline) apply and should be considered when using this device. See FDA’s drug labeling database for Rifampin and Minocycline labeling.

The use of this product in patients with compromised hepatic function should be carefully considered since rifampin can cause additional stress to hepatic metabolism. Implantation of this device would not result in detectable systemic concentrations of Rifampin or Minocycline.

Warnings: 1. This device is not indicated for the treatment of infection. If an infection develops, treat the infection aggressively.

2. To minimize recurrences when repairing hernias, the graft should be large enough to provide sufficient overlap beyond the margins of the defect on all sides.

3. An allergic reaction that is unrelated to other therapy is an indication to consider removal of XENMATRIX™ AB Surgical Graft.

Precautions: 1. Do not alter practice of pre-, peri-, or postoperative administration of local or systemic antibiotics.

Adverse Reactions: Potential complications with the use of any prosthesis may include, but are not limited to, allergic reaction or hypersensitivity to device materials or antimicrobial coating, seroma, infection, inflammation, adhesion, fistula formation, erosion, hematoma, and recurrence of tissue defect.

22

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

HERNIOLOGY

jContinued from page 21

Dr. Voeller: Disagree.

Everyone knows where I stand on this topic.

Dr. Rives, who developed the open, unilateral preperitoneal repair that the laparoscopic repair is based on, used multiple sutures for fixation in his repair. The same was true for [Dr.] Stoppa when he did a unilateral repair.

Drs. Schwab, Katkhouda, and Kes have all effectively shown that unfixed laparoscopic mesh used in inguinal repair moves and migrates if not fixed. Dr. Schwab tested sutures, tacks and glue for fixation, and fibrin glue showed the best incorporation of mesh and the best biomechanical stability of all fixation methods. No fixation at all is OK for small defects, but I want my mesh fixed— the pioneers said so and so does science.

Dr. Adrales: Agree.

At this time, I agree. However, minimal use of both

tacks and sutures should be employed to lessen the risk for post-herniorrhaphy inguinal pain. There is no firm evidence to support fibrin glue fixation as superior to traditional fixation. It may be at least equivalent, but fibrin glue is expensive and exposes the patient to potential, although rare, hypersensitivity reaction. The TISTA (Use of Human Fibrin Glue Versus Staples for Mesh Fixation in Laparoscopic Transabdominal Preperitoneal Hernioplasty) trial may demonstrate the contrary. Even so, more evidence will then be needed to determine the applicability of this randomized trial to see if fibrin glue utilization results in value for the patients in local settings.

Dr. Oleynikov: On the fence.

There are simply too many variables to consider in this kind of a situation. For instance, bilateral defects repaired with TEP [total experitoneal repair] almost always require additional fixation beyond simply glue, whereas a TAPP [transabdominal preperitoneal repair]

unilateral can usually be fixed by any means with similar clinical outcomes.

Dr. LeBlanc: Disagree.

There are ample data that verify that the use of fibrin glue is appropriate for inguinal hernia repair, either open or laparoscopic. The choice of fixation should rest on the surgeon’s ability and choice.

Dr. Sarr: On the fence.

I am not certain because there are arguments all over the place. Some say yes, some say no.

—Colleen Hutchinson is a communications consultant who specializes in the areas of general surgery and bariatrics. She can be reached at colleen@ cmhadvisors.com.

Gut Reaction: Tweeting, Watson and More Tweeting during ACS surgery

SAGES

AHPBA

IBM’s Watson

Most challenging part of my job

Biggest misconception about hernia surgery

Todd Heniford, MD

Put the iPhone down and walk away

The flagship society

Where new ideas can be discussed

Cirrhosis, metastatic tumors, transplant

Math skills meaSpeaking to famiManaging patient sure and help lies, patients after a expectations in improve outcomes successful surgery those who have complex problems

That surgeons know their long-term outcomes

Gina Adrales, MD

Unethical and narcissistic

San Francisco

Best educational society

Not for me

Jeopardy!

Terminator?

Helping patients, and getting them home

Finding enough time Durability of repairs in the obese—hernia is a symptom of a bigger health problem

Dmitry Oleynikov, MD

Whaaaat!?

Strong organization

Very relevant for new hernia techniques

Great society, very surgeon-friendly

Until they make arms for it, I am not afraid that it will take my job.

I love having patients who say “thank you”!

Having bad outcomes as a result of previous surgical misadventures by nonspecialized surgeons

Aurora Pryor, MD

Potential legal disaster

Chance to see friends across specialties

My favorite surgical society

Go-to for liver and pancreas

May be the future

I love almost every- Balancing innovathing I do. tion with expenses

That it is easy

Guy Voeller, MD

Don’t know how to tweet

Anachronistic, “abandoned” working surgeon

Excellence, training, leadership

No knowledge

Won “Jeopardy!”

Happy patients; a technically perfect operation

Non–patient care paper (computer) work

That it is easy to do

Karl LeBlanc, MD

Never; too distracting

General Progressive, wellsurgeons are run organization underrepresented

I don’t belong

Maybe too much

Complex hernia repair

Complex hernia repair

That it’s “just a hernia”

Michael Sarr, MD

Are you kidding?

Great society

Up and coming HPB society

No idea

A fixed patient

Finances of health care

That it is easy

Most progressive society

Best part of my job

ACS, American College of Surgeons; AHPBA, Americas Hepato-Pancreato-Biliary Association; SAGES, Society of American Gastrointestinal and Endoscopic Surgeons

Anyone can do it right!

WHY SETTLE FOR RESORPTION OR ENCAPSULATION WHEN YOU CAN HAVE *

REGENERATION?

SurgiMend enables strong, long-lasting hernia repair.

1-6

*SurgiMend does not trigger a detrimental foreign-body inflammatory response that would lead to rapid degradation or encapsulation.

Photograph displays cellular repopulation and revascularization of 3 mm thick SurgiMend in a small animal intra-abdominal implant model.

References: 1. Clemens MW, Selber JC, Liu J, et al. Bovine versus porcine acellular dermal matrix for complex abdominal wall reconstruction. Plast. Reconstr. Surg. 2013;131(1):71–9.

2. Adelman DM, Selber JC, Butler CE. Bovine versus porcine acellular dermal matrix: a comparison of mechanical properties. Plast. Reconstr. Surg. Glob. Open. 2014.

3. Deeken CR, Eliason BJ, Pichert MD, et al. Differentiation of biologic scaffold materials through physicomechanical, thermal, and enzymatic degradation techniques. Ann. Surg. 2012.

4. Adelman DM. Radiographic evaluation of biologic mesh repair in ventral abdominal herniorrhaphy. In: Proceedings of the American College of Surgeons. Washington DC; 2013.

5. Booth JH, Garvey PB, Baumann DP, et al. Primary fascial closure with mesh reinforcement is superior to bridged mesh repair for abdominal wall reconstruction. J. Am. Coll. Surg. 2013.

6. Cornwell KG, Greenburg AG, James KS. A generative tissue fabricated with SurgiMend has a mesothelial lining limiting adhesion formation in a model of large ventral hernia repair. In: American Hernia Society; 2010. © 2014 TEI Biosciences Inc. All rights reserved. SurgiMend is a registered trademark of TEI Biosciences Inc.

www.teibio.com

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

New Mesh Technique May Avoid Unwanted Fixation in Inguinal Hernias B Y C HRISTINA F RANGOU

S

panish surgeons have proposed a new technique for using self-gripping mesh in inguinal hernia repair that may reduce problems of accidental fixation to undesired structures during surgery.

In a report published online in Hernia, J.L. Porrero, MD, and colleagues at the Universitario Santa Cristina in Madrid described a technique in which they fold

the upper third of the mesh over the center third, hiding the microgrips that make the mesh sticky [Dec. 6, 2014. Epub ahead of print].

“This means that only the lower third of the mesh has the microgrips exposed, so it can be easily fixed to the pubic bone and inguinal ligament without undesired fixation to other structures,” they reported.

Self-gripping meshes were developed to prevent need for additional fixation during inguinal hernia repairs, thereby

reducing postoperative pain without need for mesh migration. Three-month results from a randomized controlled, multicenter, international clinical trial that compared a sutureless self-gripping mesh to lightweight polypropylene mesh in a traditional Lichtenstein repair showed that surgery duration, early postoperative pain and infection rates were significantly reduced with the self-gripping polyester (Hernia 2012;16:287-294). Longer-term results from that trial have not been reported.

June 4-6, 2015 JW Marriott

WASHINGTON, DC

Co-Chairmen: Maurice Y. Nahabedian, MD

■

Parag Bhanot, MD

Improving Outcomes with AWR 30 Years of Abdominal Wall Reconstruction An Overview

Component Separation: Anterior, Posterior, Minimally Invasive, and Robotic Approach Unique Challenges with AWR: Complex AWR and Radiated Abdominal Wall E-C Fistula Infected Mesh AWR in the Morbidly Obese Hot Topics Preoperative Imaging Enhanced Recovery Pathways The Use of Mobile Apps

www.AWRconference.com

Managed by: International Conference Management 337-235-6606 • info@AWRconference.com

A more recent meta-analysis found that self-gripping mesh was associated with a shorter operating time but no substantial improvement in pain (chronic or acute) or other complications ((Ann Surg 2014;259:1080-1085).

Some surgeons have noted that selfgripping mesh can be difficult to maneuver because it can adhere to undesired structures during positioning.

To avoid this problem, Dr. Porrero and colleagues make a small split between the lower and medium third of the mesh to mark the intended split for the spermatic cord. Using this mark, the upper third of the mesh is folded over the medium third, hiding the microgrips for all but the lower part of the mesh. This way, the mesh can be fixed to the pubic bone and inguinal ligament without sticking to undesired structures. Once the lower third of the mesh is in place, the split for the spermatic cord is completed and the upper portion of the mesh is passed below the spermatic cord. Finally, the mesh is unfolded to expose the microgrips, and the medium and upper thirds of the mesh are descended to the final position.

Senior author Oscar Cano-Valderrama, MD, a general and digestive surgeon at the Universitario Santa Cristina, said his team has used the technique in 15 patients to date and that it is an applicable approach for any patient undergoing inguinal hernia repair with a self-gripping mesh.

He said he expects patients to experience less pain with this type of mesh because no sutures are used to fix the mesh. “Nevertheless, long-term results after the use of self-gripping mesh repair are lacking and we need them before this kind of mesh is broadly used.”

Brian Jacob, MD, a hernia surgeon at the Laparoscopic Surgical Center of New York in New York City, who has studied self-gripping mesh use during laparoscopic total extraperitoneal inguinal hernia repair, said he has not had problems with the mesh sticking to unintended structures. Surgeons can use self-gripping mesh “in the creative and individualized manner” they want and patients should experience less pain because of the reduced need for fixation, he said.

“Patients have a fast recovery and we don’t have to worry as much about mesh migration, and we’re putting in less permanent fixation material. Still, only time will tell if there’s a true benefit in reduction of chronic pain and recurrence rates.”

Dr. Jacob provides consulting services for Covidien. Drs. Cano-Valderrama and Porrero had no financial interests to disclose.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

VALUE

jContinued from page 13 surgeons in private practice and academic medical centers, the AHSQC uses concepts of continuous quality improvement through patient-centered data collection, ongoing performance feedback, and improvement that is centered on analysis of collected data and collaborative learning. Participation may enable a transition to shared accountable care; peer and institutional comparison review to improve the quality, safety and cost of care; mitigate clinical and cost variations; and provide best practices, decision support and care pathways to enhance patient care and safety in the performance of ventral, incisional and parastomal hernia repair. Long-term follow-up is provided through a patient portal, uniquely allowing patients to enter outcomes information about recurrence, chronic pain and functional status.

Currently, 82 participating surgeons have enrolled more than 2,500 patients. Quarterly collaborative meetings (AHS Annual Meeting, June Collaborative conference call, American College of Surgeons Clinical Congress and December conference call) provide an open forum for data sharing and quality improvement. But how can the AHSQC transform health care delivery?

As the senior medical director for the Surgery Care Division of the Carolinas HealthCare System Medical Group, I have the privilege of leading our system-based surgeons and collaborating with our affiliated surgeons to improve patient care across 43 acute care facilities in North Carolina and South Carolina. Patients are cared for by academic and community surgeons in quaternary to rural hospitals. There are surgeons who dedicate the majority of their surgical practice to abdominal reconstructive surgery, and others who perform ventral hernia repair infrequently or refer the more complicated patient to another surgeon. No matter the patient, surgeon or acute care facility, the Carolinas HealthCare System needs to provide value to patients for all surgical care episodes.

In a system as diverse, large and geographically separated as the Carolinas HealthCare System with system-based affiliated surgeons, reducing variability in care (preoperative risk modification, herniorrhapy technique, biomaterials, etc.) has identifiable barriers. Nevertheless, participation in the AHSQC will unify patient care, promote collaboration across the health care system, stimulate sharing of best practices, and initiate disease-specific population health management. This brings value to the patient, driving progress within the health care system.

We look forward to implementing the AHSQC throughout the Carolinas HealthCare System to measure outcomes for every patient, integrate care delivery across separate facilities and expand excellent services across the Carolinas.

—Dr. Matthews is professor and chair, — Department of Surgery, Carolinas Medical Center, University of North Carolina–Charlotte Campus, and senior medical director, Surgery Care Division, Carolinas HealthCare System Medical Group, Charlotte.

SURGICAL SITE

jContinued from page 17 “Although good risk models exist, our current model may offer greater generalizability and external validity,” Dr. Fischer said.

According to Dr. Fitzgibbons, although the risk model may be valuable for predicting SSO risk after open ventral hernia repair, it is too early to say the model has been validated. “The only way to determine whether the scoring system is accurate is with prospective data, and the current study only uses retrospective

data,” he said.

Dr. Wink agreed, noting that “our risk model represents only a piece of the puzzle and was limited by what the NSQIP database had to offer.”

Given the limitations, the investigators called for future studies to expand the patient population and the follow-up period as well as to validate the risk model in a prospective fashion.

Ultimately, Dr. Wink noted, “the goal would be to create an accessible website or app based on a validated risk model that would allow surgeons to enter patient data in order to predict SSO risk.”

Another synthetic mesh removal.

And considering the average $31k cost of explantation, there goes our upfront cost savings.1

Why would you use anything other than Strattice™ Reconstructive Tissue Matrix in your Complex AWR patients?

Fact is, postoperative infection occurs in 26% of Complex AWR patients with a synthetic mesh,1 and removal of infected mesh has been shown to be 65% more costly than the average VHR admission.1,2 This can put a tremendous burden on the surgeon, the patient and the healthcare system at large.3

Strattice™ Tissue Matrix is clinically differentiated from other repair types in Complex AWR: • Can decrease downstream complications 5-fold in Complex AWR patients, and costs by 2-fold1 • Studied in more than 1,700 Complex AWR patients in 70 peer-reviewed articles 4 • <1% incidence of explantation reported in all peer-reviewed articles • Provides for a long-term repair4 1 LifeCell data on file based on a longitudinal analysis of private and public insurance claims from the Truven MarketScan® Database. Patients were followed from their initial procedure in 2007 for 18 months. (n=740).

2 Reynolds D, Davenport DL, Korosec RL, Roth JS. Financial implications of ventral hernia repair: a hospital cost analysis. J Gastrointest Surg.2013 Jan;17(1):159-66.

3 Poulose BK, Beck WC, Phillips SE, et al. The Chosen Few: Disproportionate Resource Use in Ventral Hernia Repair. Am Surg. 2013 Aug; 79(8):815-8..

4 Searches performed on PubMed, Google, Google Scholar and ScienceDirect® in September 2014. Each study was considered independent during calculation.

Studies may contain overlapping patient populations.

Before use, physicians should review all risk information, which can be found in the Instructions for Use attached to the packaging of each LifeCell™ Tissue Matrix graft.

© 2015 Acelity Corporation. All rights reserved. Strattice™ is a trademark of LifeCell Corporation. MLC4068-R1/4404/1-2015

26

Opinion LAP HERNIA

jContinued from page 13 posterior repair. In 1992, I presented our first series of repairs at the American College of Surgeons Clinical Congress, and was told not only was I “crazy, but that [I] couldn’t be doing that many hernias if [I wasn’t] a hernia center.” I therefore returned to California, told my associate that we were now the Center for Hernia Repair and continued to collect patients and data.

Although our first repairs were overkill according to today’s standards, only one of the first 100 patients have ever had a recurrence, and it was a retained lipoma.

We performed a transabdominal preperitoneal (TAPP) repair, but the name didn’t come until later, and we used way too much mesh (two layers) for routine hernias. Slowly, the techniques evolved, and fortunately our results continued to be good, and the morbidity of the procedure remained low.

In 1993, or around that time, a small company named Origen came to me and asked if I would be willing to try their new product to perform a completely extraperitoneal laparoscopic hernia repair. There were a few brave surgeons ( J. Barry McKernan and others) trying this approach, but without the aid of a balloon dissector. Because Dr. Nyhus was constantly objecting to my invasion of the peritoneal cavity with the TAPP repair, I thought it was worth a try.

In 1995, I published my experience with the totally extraperitoneal (TEP) laparoscopic inguinal hernia repair. I demonstrated that the results of the two approaches, TAPP and TEP, were equal, but as you know, the controversy still goes on today. The benefits of each will be discussed later in this article.

About this time, I was introduced to Dr. Guy Voeller, a surgeon from the opposite side of the country and a true southern gentleman. It was reinforcing to my own belief in the laparoscopic TEP repair to find that there was another surgeon, this one from Tennessee, coming to the same conclusions about this technique. Although we were initially unaware of each other’s work, both Dr. Voeller and I based our TEP approaches on true open posterior repairs of well-known and respected surgeons (Drs. Nyhus, George Wantz and Rene Stoppa).

Over the next several years, both of us ran courses on TEP repairs and traveled the globe promoting this new approach. Sometimes our ideas were well received, and other times surgeons were resistant. Adoption of laparoscopic repairs, TAPP or TEP, was slow, and varied from region to region and country to country. There were several reasons for this resistance, although most have slowly been resolved. The problems included: 1. Many initial published reports had dismal outcomes. This situation existed because many authors were eager to publish their experience and did so during their learning curves or without proper practical education. As time passed and publishing authors gained experience, results equaled or bettered reports from authors using a variety of open techniques. At first, only nonrandomized studies demonstrated favorable results ((J Laparoendoscopic Surgg 1993;3:1-8; Surg Endoscc 1998;12:226-231), but now, many randomized studies written by experienced laparoscopic surgeons have confirmed the value of the laparoscopic approach.

In fact, the incidence of long-term pain has been shown to be less with the laparoscopic approach (J ( Surg Res 2014;192:409-420; Br J Surgg 2010;97:600-608).

2. The laparoscopic approach was difficult to learn for surgeons and it took a great number of cases to perfect the approach. Surgeons became easily discouraged.

Now surgeons are much more laparoscopically skilled and experienced when they begin to use the laparoscopic approach. The time it takes to become a laparoscopic hernia surgeon is therefore less, and surgeons quickly appreciate the skills needed to succeed. In addition, there are many more skilled laparoscopic hernia surgeons to mentor the aspiring surgeon.

3. Insurance companies actually pay less for laparoscopic repairs and, therefore, financially discourage many surgeons from making the effort. This thankfully has become a non-issue for most surgeons because doing what is best for the patient trumps financial gain for most surgeons.

4. The cost of laparoscopic hernia repair was higher than open repair. This may still be the case, but the difference has decreased or even disappeared over time (Surg Laparosc Endosc Percutan Tech 2008;18:70-74; Br J Surgg 2010;97:765-771; Surg Endoscc 2013;27:13261333). Studies have also shown that total cost to the patient, including lost work time, is actually in favor of the laparoscopic approach.

5. Finally, it is sometimes difficult to teach old dogs new tricks. Surgeons become very comfortable with the way they are taught to approach problems and are hesitant to change. Now there is a whole new crop of surgeons approaching hernia surgery; all are laparoscopically trained and that hesitancy is not there. In fact, the new surgeons are eager to do everything laparoscopically, especially hernia repair.

After 25 years performing laparoscopic inguinal hernia repair, what have I learned and is any of it of value to you, the reader? You will have to decide for yourself, but I hope there may be at least a couple of ideas that reinforce what you already do or cause you to adjust your surgical habits. Disclaimer: The opinions are those of an aging surgeon with a keen interest in the future of laparoscopic hernioplasty and, therefore, are definitely biased, but bias is a privilege of age. Most of the opinions are based on published data, but a few are based on my own 25 years of experience performing thousands of laparoscopic hernia repairs.

Who should perform laparoscopic hernia repair?

I would like to say the answer is everyone, but this is definitely not the case. Laparoscopic hernioplasty is a complicated procedure because it is made up of three essential components: knowledge of anatomy, laparoscopic technical skills and the hernia repair itself. Before performing a laparoscopic hernia repair, one must become familiar with the posterior anatomy. Although it would seem that the posterior anatomy should be constant, the initial appearance can vary widely and does not become totally obvious until the dissection is complete. This can be discouraging to the novice hernia surgeon, but with experience, a strong knowledge of the landmarks and careful dissection moving from the known to the unknown areas, anatomy is not a deterrent to performing a safe and quality repair.

Laparoscopic hernioplasty requires multiple technical skills, but now that residents are perfecting these skills during training or fellowship, this stumbling block has been eliminated. Finally, knowledge of the repair itself is essential. Mesh size, complete dissection of the posterior floor and proper placement of the mesh are now well defined.

So, who should be performing laparoscopic hernia repair? My opinion is it should be a surgeon that is willing to take the time and training to achieve these three components of laparoscopic hernia repair.

Is one laparoscopic approach truly better than the other? Theoretically the answer is yes, but in actuality, the answer is probably not.

Is a laparoscopic hernia repair for every hernia?

Twenty-five years ago, my answer would have been yes, but how age and experience mellow you! Whether it’s a unilateral, bilateral, primary, recurrent reducible or incarcerated, the laparoscopic approach is my approach of choice. If the hernia is incarcerated and cannot be reduced under anesthesia, a TAPP approach should be used to identify what is incarcerated, where it is incarcerated and the viability of the incarceration. Using simple techniques, the hernia can be reduced, the bowel resected if necessary, and the hernia repaired.

Today, I sincerely believe that there are, however, hernias, patients and situations when an open repair is not only equal to the laparoscopic repair in all respects, but also significantly safer. Patients who are not a good risk for general anesthesia should have an open repair under local anesthesia. Yes, the laparoscopic repair can be done under regional anesthesia, but why? If a patient has had contamination of the extraperitoneal space by a previous prostatectomy, radiation or other pelvic surgery that may have obliterated the extraperitoneal space, why take the risk for a bowel or bladder injury when an open repair would be much safer?

There are surgeons that do not hesitate to perform laparoscopic repairs in all of these patients and I was one of them, but the years have definitely changed my opinion. Just because you can do it doesn’t mean you should. One needs to weigh the risks of a procedure versus the benefits for each patient you take to the operating room.

Should an asymptomatic hernia found at the time of laparoscopic hernia repair be fixed? Many surgeons recommend looking for and repairing the opposite side at the time of unilateral laparoscopic repair. In the TAPP repair, it’s just a matter of inspection. In a TEP repair, one must expose the opposite side to determine if there is a hernia. This dissection, however, may in fact

27

result in a hernia if the dissection is left unrepaired. In my experience, the majority of contralateral hernias can be felt with an adequate exam and I, therefore, do not recommend exposing the opposite side when doing the TEP repair. Fixing the asymptomatic, nonpalpable hernia is really of dubious benefit. It is true that 10% to 15% of patients will develop a hernia on the opposite side. It is, therefore, tempting to look for the asymptomatic hernia to avoid a second operation, but remember it is difficult to make an asymptomatic patient better.

If they develop postoperative pain in the asymptomatic repaired side that neither the patient nor you knew they had before surgery, litigation is not uncommon. In fact, in one study, less than 4% of patients developed a second hernia when the second side was not explored at the original TEP procedure (Herniaa 2010;14:481-484).

My recommendation, therefore, is to nott fix it if you cannot feel it preoperatively and discuss the risks and benefits of repair.

Is fixation necessary? We have been asking this question since the beginning of laparoscopic hernia repair. In the beginning, only a few surgeons dared to place mesh without multiple points of fixation with staples, or later tacks. Soon it became apparent to many of us that fixation was unnecessary. Recurrence rates were less than 1% whether mesh was fixed or not, and postoperative pain was decreased when the mesh was not anchored.

Recently, surgeons have advocated novel means of fixation such as glue or self-fixing mesh. They feel that these techniques will decrease pain associated with sharp fixation of the mesh without leading to an increase in recurrence. In fact, they feel it will decrease recurrence by anchoring the mesh below the iliopubic tract, where tacks cannot be placed. This opinion, however, is theoretical until the data prove that these new forms of fixation are actually better than no fixation at all. My recommendation is to not use fixation of any kind except in a few situations. If the mesh will not lie flat against the abdominal wall (it is being held up by the testicular vessels) or the patient has already had multiple recurrences, then fixation is probably useful and worth the cost. I await the randomized studies of novel fixation methods versus no fixation at all.

TAPP or TEP: Which Is Best? Most of us began with a transabdominal repair 25 years ago. I remember

a meeting held by one of the surgical device compa- perform totally extraperitoneal inguinal hernia repair nies bringing many of the early adopters of laparoscopic with manual dissection rather balloon dissection of the hernia together to exchange ideas. A couple of mav- extraperitoneal space, but most surgeons prefer the balerick surgeons suggested that we could approach the loon because it so easily and rapidly performs the same hernia without violating the peritoneal cavity (a total- dissection. My preference is the original round balloon ly extraperitoneal approach). Not being very innovative, because it dissects the extraperitoneal space without most of us quickly rejected their opinion. We thought it dissecting the opposite side or taking down the infewas too difficult and would lead to subcutaneous escape rior epigastric vessels. The extra cost of this balloon is of carbon dioxide. It wasn’t until the balloon dissector made up by the time saved in performing the dissection. was introduced that a few more of us saw the potential advantages of the totally extraperitoneal approach. The Does the type of mesh matter? Over the last 25 years rest is history. Many of us spent the next several years there have been many attempts to improve on laparoperforming hundreds of extraperitoneal repairs per year scopic inguinal hernia repair by altering the mesh. and teaching the technique to as many surgeons as we What has not changed is the size of the mesh. Early could find who would listen. Laparoscopic hernia repair on we found that too small a mesh leads to failure and quickly spread around the world, and surgeons’ adop- recurrence. The composition of the mesh has been tion of the approach ranged from 10% to 20%. questioned. Lighter and larger pore meshes have been As discussed earlier, most surgeons were resistant to introduced in the hope of decreasing chronic pain withchange, but recently there has been a reversal of atti- out increasing recurrence. To me the literature, however, tudes for the reasons outlined above. Is one laparoscop- has been confusing. There are studies showing decreased ic approach truly better than the other? Theoretically postoperative pain with lighter weight meshes and there the answer is yes, but in actuality, the answer is prob- are studies that fail to show any difference (Surg Endosc ably not. The extraperitoneal approach does avoid the 2010;24:2735-2738; Hernia 2011;15:503-510). Some peritoneal cavity and the potential for injury to the have even shown a higher recurrence rate with largintraabdominal viscera; it eliminates having to close the er direct hernias and lightweight meshes. My personperitoneum; it keeps the mesh away al experience with conventional mesh has My personal from the viscera; and it may be quickbeen very satisfactory and chronic pain has er to perform. In fact, in the hands not been an issue. Only time and wellexperience with of experts, there is no difference controlled studies will establish the value in rates of complications or recur- conventional mesh of these newer lighter weight meshes. rence between the two approaches has been very (Surg Endoscc 2012;26:3355-3366). I Should robots be used to perform lapsatisfactory and still prefer the TEP approach, howaroscopic hernia repairs? I have a definite ever, and reserve the TAPP for spe- chronic pain has not bias against robotic repairs. It is simple cial cases such as large scrotal hernias, and quick to perform conventional lapabeen an issue. recurrent laparoscopic hernias, and roscopic repairs, and I wonder why surcases where a look into the peritoneal geons would find the need to add a robot cavity for diagnosis is essential. All of between themselves and the patient. Is it us have a surgical bias, but the key is to do whatever we cheaper, faster or better than a conventional TEP or choose and do it safely.

TAPP repair? What is the advantage that would make the robotic surgeon choose to complicate and elevate How should recurrent hernias be repaired? Most the cost of the repair? Many of my hernia friends argue surgeons would agree that if the original repair was an that if I fought for innovation in the past, why don’t I open anterior approach, then a laparoscopic repair of the see the robot as the natural progression of laparoscopic recurrence is appropriate. Where disagreement occurs is inguinal hernia repair for the future? I remain open to when the original repair was laparoscopic. Many sur- their research as long as their techniques with the robot geons that are advocates of the laparoscopic approach adhere to the principles of hernia repair established over for open recurrences advise against laparoscopic repair the past 25 years. I will remain skeptical, however, until of laparoscopic failures. My bias is to approach all lap- I see the appropriate data, and hope that robotic repair aroscopic failures with a TAPP approach. Not only will not become a replacement for other hernia repairs does it allow the surgeon to diagnose exactly why the until its true value is established. The robot could be the first repair failed, but it can be performed safely and straw that breaks the camel’s back! successfully with experience. Mesh placed previousHopefully, I haven’t bored you with the memories ly should be left in place and additional mesh added and opinions I have gathered over the past quarter-cento repair the recurrence as needed. Suturing techniques tury of laparoscopic hernia repair. Hopefully, you now may be required to close the peritoneum. If, after per- have an appreciation for how we got to where we are forming the diagnostic portion of the laparoscopy, the today and why I am such an advocate of this approach. surgeon feels it is too difficult or risky to continue lap- Finally, I am hopeful that after reading this brief history aroscopically, an open procedure can be performed to of one surgeon’s personal experience, you will be stimucomplete the repair. Some surgeons have advocated a lated to offer your patients the benefits of laparoscopic TEP approach for the repair of recurrent laparoscopic inguinal hernia repair and will be stimulated to improve repairs, but I feel this approach is much more difficult upon the first 25 years of laparoscopic inguinal hernioand has the potential for complications related to the plasty. Whether that is the development of new instruscar tissue from the previously placed mesh. mentation, better meshes or even robotic repair will be up to the next generation of hernia surgeons. What I What is the role of a balloon dissector in TEP am sure of is that laparoscopic repair will continue to repairs? As noted earlier, the balloon dissector simpli- increase and results can only improve. fied the initiation of the TEP repair and helped spread its popularity among laparoscopic surgeons. Is it really necessary? There is no question that some surgeons —Dr. Felixx is a general surgeon in Santa Maria, Calif.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015 ISSUES FOR THE BARIATRIC & METABOLIC PROFESSIONAL

Extended Quarterly Coverage

Robotics in General Surgery: Procedure by Procedure ‘Does the platform that currently exists or the platforms that are coming out … going to be enabling to allow you to do better surgery? That’s the only question that needs to be answered.’

This Installment: Experts Discuss the Robot For Bariatric Procedures B Y C HRISTINA F RANGOU SAN FRANCISCO—There is one certainty about the use of the robot in general surgery: The platform is controversial. But on everything else regarding the robot, little agreement exists.

The 2014 Clinical Congress of the American College of Surgeons featured a panel session on robotics, entitled “Robotics for General Surgeons: What’s Proven, What’s Not.” Over the next months, General Surgery News will present a review of robotics in general surgery, based on the panel presentations. Our stories will highlight the largest worldwide robotic experiences in hepatobiliary and pancreatic, bariatric, upper gastrointestinal, colorectal, endocrine and thoracic surgery, and compare the results with published literature and global standards. We will have input from surgeons on all sides of the robotic debate.

We start this month with an overview of robotics in bariatric surgery.

When Erik B. Wilson, MD, professor of surgery at the University of Texas Medical School, Houston, started using robotic surgery in bariatric patients 12 years ago, he never would have predicted that this high-tech approach would still be contentious more than a decade later.

“I would have been very surprised,” he said. He added, “But I think there’s a lot of reason for it. There are significant barriers to robotic surgery still—cost, capital cost, surgeon training.”

Dr. Wilson, who has amassed one of the world’s largest robotic bariatric series, argues that two learning curves exist in robotic bariatric surgery: a first curve of about 10 to 15 cases as a surgeon becomes safe using the robot, and a second, much longer learning curve of around 100 cases as a surgeon becomes efficient and offers significant value by using the robot.

As a leader in robotic bariatric surgery, Dr. Wilson often is asked by surgeons if they should add robotic foregut surgery to their practice. The past president of the Clinical Robotic Surgery Association usually responds with a question of his own, asking surgeons if they think the technology would be “enabling” in their practice.

“Does the platform that currently exists or the platforms that are coming out … going to be enabling to allow you to do better surgery? That’s the only question that needs to be answered. If it’s enabling your practice, then at some

—Erik B. Wilson, MD

point in time you’re probably charged to do it well. If it’s not enabling in your practice, then it’s easy to justify not doing it.”

Robotic bariatric surgery is growing in popularity but still accounts for a small percentage of bariatric procedures done in the United States. Today, Dr. Wilson estimates about 10,000 robotic bariatric cases are performed each year. That is a small proportion of the more than 200,000 bariatric procedures done in the country each year.

Advocates of robotic surgery say the platform offers several advantages over the standard laparoscopic approach in bariatrics: The robot removes counterintuitive motion and instrument tremor; it is ergonomically beneficial to surgeons; it provides three-dimensional visualization; the robot’s “wrists” function

similarly to a surgeon’s natural wrists; and an accessory arm allows the surgeon to retract without an assistant (World J Surgg 2013;37:2756-2760).

But bariatric surgery, similar to other areas of general surgery, has not been subject to large-scale studies of the robot in head-to-head trials with laparoscopic surgery. The studies that have been done are generally single-center, often retrospective reviews; only a handful of these directly compare laparoscopic and robotic procedures. The reports tend to focus on complications, cost, operating room times and length of stay; no studies have examined long-term bariatric and metabolic outcomes.

The largest series in robotic bariatric surgery to date comes from Dr. Wilson in Texas and two colleagues who work in

high-volume bariatric centers in Maine and Florida. Among 1,695 patients who underwent robotic Roux-en-Y gastric bypass in this series, investigators reported a 30-day mortality rate of zero, with leaks occurring in two patients (0.12%) and abscesses in three (0.18%) (World J Surgg 2013;37:2756-2760).

“Even if leaks and abscesses are combined, this remains an exceptionally low infection rate after gastric bypass, which is favorable against any leak rates reported in the literature,” Dr. Wilson said.

Other smaller series of robotic gastric bypass confirm low rates of anastomotic and staple-line leaks, a finding that authors of a recent meta-analysis attribute in part to “improved accuracy and precision of intracorporeal suturing compared to the traditional laparoscopic approach” (BMC Surg 2013;13:53).

The Italian surgeons who conducted the meta-analysis concluded that “the major strength of the robotic surgery is strongly facilitating some of the surgical steps (gastrojejunostomy and jejunojejunostomy anastomosis in the robotic Roux-en-Y gastric bypass or the vertical gastric resection in the robotic sleeve gastrectomy).”

They noted, however, that the analysis was limited by the small number and low quality of studies, small sample size, heterogeneity of patients and lack of data from metabolic and bariatric outcomes. They added, too, that the major disadvantage of robotic bariatric surgery “remains the high operational and acquisition cost of the system.”

Dr. Wilson summarized the evidence for robotic bariatric surgery by saying the approach is safe but not safer than laparoscopic surgery. “That’s a very hard argument to make. In our hands, it’s better with the robot. We would not say that everyone has to use the robot,” Dr. Wilson said.

Robotic sleeve gastrectomy is “a harder sell” than robotic gastric bypass, he said.

Only a few studies compare robotic and laparoscopic sleeve gastrectomy. see BARIATRIC ROBOTICS PAGE 30

29

30

In the News BARIATRIC ROBOTICS jContinued from page 29

Dr. Wilson’s group performed a comparative study of 277 laparoscopic sleeve gastrectomies to 40 robotic sleeve gastrectomies (World J Surgg 2013;37:2756-2760).

Of note, the procedures were performed by several surgeons.

Operating room times were 22 minutes longer with the robotic approach, at 113 minutes. However, laparoscopic leak rates were higher with a 1.8% leak rate in the laparoscopic arm and zero in the robotic arm.

Still, the numbers are far too low to draw any conclusions.

“More studies comparing techniques obviously need to be done for primary sleeve gastrectomy; current data show no obvious clinical advantages,” wrote Dr. Wilson and co-author Ranjan Sudan, MD, associate professor of surgery, Duke University Medical Center, Durham, N.C., in their report.

One of the challenges for sleeve gastrectomy as a robotic procedure is that it is relatively straightforward to perform laparoscopically, making it difficult to justify the more expensive, more time-consuming robotic approach, Dr. Sudan said in an interview.

But, he said, robotic sleeve gastrectomy is a very good learning case for surgeons, in which they can develop some of the movements required for more complex operations such as mobilizing the hiatus, suturing to reinforce the staple lines and taking out the short gastric vessels from the spleen in preparation for more complex robotic bariatric procedures, he said.

“If you compare head-to-head a robotic sleeve gastrectomy with a laparoscopic sleeve gastrectomy, you’re not necessarily going to see any advantages for the robot. In fact, time and cost are probably going to favor the laparoscopic approach,” Dr. Sudan said.

“That’s why, in my own practice, I’ll do the sleeves and a straightforward gastric bypass laparoscopically to be time- and cost-efficient, and I don’t think there’s much difference in terms of pain or complications.”

But surgeons who are training to use the robot for more complex procedures, which many surgeons argue are the procedures where the real advantage of the robot is evident, should start by doing simpler bariatric procedures with the robot.

“I think it makes sense to use simpler bariatric operations as a bridge to learning robotics to do more complex cases,” Dr. Sudan said.

Proponents of robotic surgery often argue that complex cases, revisional cases or patients with a body mass index (BMI) greater than 60 kg/m2 show better clinical results with the robotic approach. Again, there is limited published evidence to support this argument.

The Italian group that authored the 2013 meta-analysis concluded that “the assumption that robotic surgery is superior in complex cases is not supported by the available present evidence.”

Dr. Sudan uses the robot to perform biliopancreatic diversion with duodenal switch (BPD/DS), a difficult procedure that he first started as robot-assisted in 2000, and has now evolved into a totally robotic approach.

Having performed nearly 500 robotic cases, Dr. Sudan reported zero mortality and low complications with the primary BPD/DS, with no complications, which compares favorably to outcomes reported for the laparoscopic approach (Surg Endosc 2014 Jul 2. [Epub head of ahead of print]; Ann Surgg 2012;255:940-945).

Dr. Sudan believes the robot is a very useful tool for the duodenal switch procedure. “I think for the

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

duodenal switch there is definitely a role, particularly for doing the duodenal–ileal anastomosis because that’s a pretty difficult anastomosis to do and is unforgiving if it leaks. We’ve been able to get the duodenal switch done with really good results, even for highBMI patients,” he said.

The challenge is for surgeons to develop their robotic skills to the point where they can perform complex procedures, he said. His own research suggests the learning curve for robotic BPD/DS is about 50 cases when starting with minimal robotic skills or laparoscopic skills ((Ann Surgg 2012;255:940-945).

”If you want my honest opinion, that is the one strongest advantage of roboticassisted surgery: the ability to operate while seated. It is obviously ergonomically attractive.“ —Samer Mattar, MD Drs. Wilson and Sudan maintain that the robot may be advantageous in revisional cases. As more people undergo bariatric procedures, a commensurate number of patients will require revisions due to incomplete or poor weight loss. These operations are substantially more difficult than first-time bariatric cases. Two single-center studies, both with fewer than 100 patients, have shown that robotically-assisted revisions can be performed safely and result in further weight loss (World J Surg 2013;37:2569-2573; Surg Obes Relat Dis 2011;7:546-547). In Dr. Wilson’s series, the leak rate was 1%, far lower than the 10% to 15% reported in series of laparoscopic revisional surgery, he said.

Many bariatric surgeons in the United States say they remain unconvinced that the robot offers clear advantages for patients.

Samer Mattar, MD, professor of surgery and chief of bariatric surgery at Oregon Health & Science University, Portland, said he has yet to see any published evidence that demonstrates improved outcomes or cost savings with robotic bariatric surgery.

He listed several concerns about the robot, including cost (“remember there are no billing codes for robotic surgery”) and lack of tactile feedback, potentially compromising suturing and/or tissue-handling maneuvers.

He said he is concerned with the way hospitals market robotic and robotic-assisted surgery: They make claims about the benefits of the new approach without providing evidence that this platform offers any advantages over laparoscopic surgery.

“This sends an incomplete message to the community and referring physicians. As a result, patients now often demand to have robotic surgery, thinking that this will result in less pain and better outcomes which has not been demonstrated to be true when compared with laparoscopic procedures.”

Still, Dr. Mattar said he might consider using the robot in the future to help take the pressure off his neck and shoulders in the operating room. “If you want my honest opinion, that is the one strongest advantage of robotic-assisted surgery: the ability to operate while seated. It is obviously ergonomically attractive.”

Peter T. Hallowell, MD, director of bariatric surgery at the University of Virginia, Charlottesville, is

watching the data closely. So far, he sees no significant benefit for bariatric patients to be treated robotically. He cited a recent study published in Surgical Endoscopyy that showed, based on an analysis of nearly 100,000 surgical procedures recorded in the University HealthSystem Consortium clinical database from October 2010 to February 2014, no significant difference in in-hospital mortality or major complications between laparoscopic and robotic techniques for bariatric and general surgery procedures. Only two procedures showed improved outcomes with the robotic approach and, even then, only in hospital length of stay: Heller myotomy and cholecystectomy. Costs were 21% higher in the robotic group for all procedures (Surg Endosc 2014 Oct 16. [Epub head of print]).

“I would consider using the robot in the future if there appears to be a benefit: Think rectal surgery, prostatectomy, radical hysterectomy,” Dr. Hallowell said, in an email.

Costs remain a major concern with the robot, although newer generations may reduce the cost by adding a stapling platform. “I do believe we have a responsibility to manage costs and this is one of the biggest problems with the robot.”

In an email, Ninh T. Nguyen, MD, chief of gastrointestinal surgery, University of California, Irvine, said it is up to each surgeon to decide whether he or she can offer a better procedure with the robot.

“There is definitely a role for it, but the question is can you offer the same outcome with laparoscopy alone, and the answer is yes. Therefore, if you ask me, [the] robotic role is limited, as I can do all of my cases using laparoscopy alone and robotics increase operative time for me as the setup is longer.”

Stephen Archer, MD, a general/bariatric surgeon in Bend, Ore., transitioned to robotic bariatric surgery about 18 months ago. So far, he has performed about 120 cases robotically and is happy with the results.

“I transitioned because I was interested in the ability of the robot to help with complex reoperations, which I see a fair number of because I am in a somewhat more remote area,” he said. He acknowledges that there is “no statistical advantage” to robotics in bariatric surgery with regard to clinical outcomes and most studies show a disadvantage in price.

Even so, he finds several advantages in terms of visualization, precise movements and, most importantly, ergonomics. “I can say that for me, the ergonomic advantage of the robot has made it worth it for me personally, and I believe it will allow me to operate for more years in better health.”

Several supporters of robotic surgery said the robot has an additional advantage: to capture data.

“I believe the robot’s unique ability to provide precise data on operative times, instrument usage and other variables will help us to learn how to utilize it to save money and time,” Dr. Archer said.

Dr. Wilson noted, “It’s a way of grading surgeons, so I think hospitals are really going to be excited about the fact that by putting a robot between the surgeon and the patient, they can get all these measurements.”

Dr. Wilson reported being a consultant for Intuitive Surgical, which designs, manufactures and markets da Vinci Surgical Systems. Dr. Archer serves as a speaker and proctor/mentor for Intuitive. Other sources reported no relevant financial relationships.

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Study Offers Clues on How Bariatric Surgery Improves Congnition Reduction of Inflammation and Metabolic Syndrome B Y K ATE O’R OURKE BOSTON—For years, clinicians have known that neurocognitive function improves after bariatric surgery, but little has been known about what exactly drives this. Now, a new study presented at Obesity Week (abstract 1001) provides some clues.

“Weight loss and improvements in inflammation and metabolic syndrome are correlated with improvements in memory and attention,” said lead author of the study John Morton, MD, director of bariatric surgery at Stanford University School of Medicine, in Standford, Calif., and president of the American Society for Metabolic and Bariatric Surgery.

Growing evidence has linked obesity with poor neurocognitive function and the risk for developing dementia and Alzheimer’s disease ((J Alzheimers Diss 2012;30:S89-S95). Studies also have shown that indviduals who undergo bariatric surgery realize improvements in memory and other cognitive domains ((Am J Surgg 2014;207:870-876).

But what spurs these gains? By undergoing bariatric surgery, individuals not only lose a significant amount of weight, but they also have significant improvements in glycemic control, metabolic syndrome (MetS), depression and daytime sleepiness, all of which could independently improve cognition.

To pinpoint the specific mechanisms involved, Dr. Morton and his colleagues enrolled 47 consecutive bariatric surgery patients. The average preoperative body mass index was 46 kg/m2; the average age was 48.1 years; 32.6% of patients were diabetic; and 43.9% of patients had MetS. Study participants completed a battery of cognitive tests before surgery and then at three, six and 12 months after bariatric surgery. The cognitive tests included the revised Hopkins Verbal Learning Test (HVLT), a brief verbal line learning and memory test with six alternate forms; the Digit Symbol Substitution Test; and Trail Making Tests A and B. Patients also completed the Beck Depression Inventory-II; the Epworth Sleepiness Scale; and the Psychomotor Vigilance Task-192, a validated measure of reaction time and psychomotor function.

Preoperative test scores showed that patients were well below population averages in HVLT immediate recall (T score 38.3) and HVLT delayed recall (T score 41.4), and had slower mean response speeds on the Psychomotor Vigilance Task-192 (norms 2.48 seconds vs. patients

3.63 seconds; P<0.05).

Diabetes was the single biggest factor found to affect cognitive scores, according to the researchers. Patients without preoperative diabetes had significantly faster times on Trail Making Test B (diabetes 90.4 seconds vs. no diabetes 63.1 seconds; P=0.039).

P “The brain is a big consumer of glucose for its size,” said Dr. Morton. “It consumes

a lot more glucose than your heart or your muscles. It really needs it, and when there are derangements in the glucose metabolism, some of the brain chemistry doesn’t work as well.

The actual synaptic firings across neurons are impeded.”

At 12 months postsurgery, patients had improved memory and attention, as measured by the HVLT

immediate recall (+2.63; P P=0.004), the HVLT delayed recall (+1.04; P=0.003) P and the Trail Making Test A (–7.25 seconds; P<0.001). Changes in sleepiness and depression did not correlate to changes in cognitive function. Patients without preoperative MetS had significantly greater three-month improvements in HVLT immediate recall (MetS +0.50 vs. no MetS +4.14; P P=0.024). Improvements in HVLT immediate recall were strongly correlated see BARIATRIC BRAIN page 33

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In the News READMISSIONS jContinued from page 1

that one in every 20 patients who undergo bariatric surgery in the United States will be readmitted to hospital within 30 days, according to an analysis of 18,296 primary bariatric procedures performed in 2012 and reported to ACS’s National Surgical Quality Improvement Program.

The analysis revealed several key risk factors associated with readmission. Many of these factors are things that bariatric surgical teams can address pre- and postoperatively, Dr. Morton said.

“We can decrease readmissions with a lot of commonsense things that can be done at the right time for the right patient,” he said. Recommendations include dietary counseling about food and water intake and having patients fill prescriptions before discharge from the hospital.

The study comes as the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), a program that establishes national standards for facilities and surgeons performing bariatric surgery, launches its first national quality improvement project, Decreasing Readmissions through Opportunities Provided, known as DROP. DROP aims to reduce readmissions within 30 days of surgery by 20% at 700 accredited bariatric centers throughout the United States, which could prevent approximately 1,500 bariatric surgery readmissions and save about $525 million.

Beginning in February 2015, the program will be rolled out at about 100 randomly selected bariatric surgery centers in the United States. DROP will be implemented and evaluated over the next 12

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

months before a final version is extended to all MBSAQIP centers, said Stacy Brethauer, MD, associate director of Cleveland Clinic’s Bariatric and Metabolic Institute, in Cleveland.

DROP was first piloted in 2008 by Stanford’s bariatric surgery department.

Over several years, Stanford reduced its bariatric surgery readmissions by 75% by implementing changes in patient education, discharge planning and pre- and postoperative checklists. Among the changes, staff provided patients with a help card that listed phone numbers for patients to call if they had concerns, which often saved them a trip to the emergency department. Patients were given branded water bottles to emphasize the need for proper hydration. Staff put together a detailed discharge checklist that included questions about home care, nutrition and pain. After patients were discharged, a registered nurse called each patient at home the next day to check in on them.

For patients having problems, same-day appointments were made readily available.

By 2012, readmissions fell to 2%, down from 8% four years earlier.

“When we drilled down into the causes, we were able to significantly decrease readmissions. We Risk Factors for Readmission After Bariatric Surgery • • • •

Body mass index >50 kg/m2 Longer operating time Hospital length of stay >4 d Preoperative diabetes diagnosis

hope to pass that on to other centers,” Dr. Morton said.

Based on Stanford’s experience, DROP organizers put together videos for patients to watch prior to surgery and set out multidisciplinary care bundles that can help manage care components such as dehydration, dietary concerns and medication issues.

In the study presented at the ACS meeting, the most common readmissions were related to gastrointestinal (45%), dietary (33.5%) and bleeding (6.57%) problems, that bariatric surgical programs can target by careful discharge planning, Dr. Morton said. “That’s where you see opportunity for improvement,” he pointed out.

The study also identified patients at high risk for readmission. Patients who were readmitted to hospital were more likely to have a body mass index greater than 50 kg/m2 (30.2% vs. 24.6% for patients who were not readmitted; P<0.001); have a longer operating time (115 vs. 132 minutes; P<0.001), have a hospital length of stay of more than four days (9.57% vs. 3.36%; P<0.001) and have a preoperative diagnosis of diabetes (31.1% vs.

27.7%; P<0.02).

Postoperative Risk Factors Associated With Return to Hospital • Surgical site infections • Urinary tract infections • Deep vein thrombosis • Return to operating room

“What’s helpful about that is [that] for patients at a higher risk of readmission, we escalate coordination of care early on,” Dr. Morton said.

The study also showed that complications are the primary cause of readmission.

Postoperative factors associated with a return to hospital included surgical site infections (15.5% vs. 1.15% among patients who did not have a readmission to hospital), urinary tract infections (3.65% vs. 0.65%), deep vein thrombosis (3.58% vs. 0.13%) and, most significantly, a return to the operating room (22.6% vs. 0.92%; P<0.001 for all).

Logistic regression analysis found that readmission was significantly associated with complications, with an odds ratio of 11.3 (P<0.001).

The DROP program does not address complications, but future MBSAQIP quality initiatives will focus on complications, Dr. Brethauer noted. “One of the take-home messages from this study is that preventing complications from the primary surgery probably will go the farthest in preventing readmissions in our specialty.”

Richard D. Stahl, MD, assistant professor and medical director of bariatric surgery, University of Alabama at Birmingham, said bariatric surgery in the United States has made great strides over the past decade by paying attention to detail, learning from colleagues and never being content with the status quo.

“I think it’s in this vein that the DROP program should be viewed, and why it is so admirable …. They think, and I think, we can do better and that, after all, is the mission of all dedicated bariatric surgeons. If we can make [bariatric surgery] better, then it is unacceptable not to improve,” Dr. Stahl said.

Trial Provides Concrete Data for Closing Defects During Gastric Bypass B Y K ATE O’R OURKE BOSTON—Closing the mesenteric defects in laparoscopic gastric bypass surgery reduces the risk for internal hernias and operation for small bowel obstruction, according to results from a randomized controlled trial.

The study, presented at Obesity Week 2014, is the first randomized trial to investigate the issue.

“This is a good paper,” said Alfons Pomp, MD, chief of gastrointestinal metabolic and bariatric surgery and the Leon C. Hirsch Professor of Surgery, NewYorkPresbyterian Hospital/Weill Cornell Medical Center, New York City, who was not involved with the study. “[Our group] has been talking about this for over a decade and convincing people, gradually, that these defects need to be closed.”

Small bowel obstruction due to internal hernia is a major problem of the laparoscopic Roux-en-Y gastric bypass (RYGBP), occurring in 10% of procedures (Obes

Surgg 2011;21:1822-1827). Many centers close the mesenteric defects routinely at the time of RYGBP, but the evidence for this practice is minimal. The studies suggesting a benefit to this practice are retrospective or noncontrolled trials (Obes Surgg 2006;16:1482-1487; 2007;17:1283-1286; 2009;19:527-530). A 2013 editorial in Surgery for Obesity Related Diseasess by Mathew Martin, MD, a surgeon with Madigan Army Hospital, Tacoma, Wash., pointed out that there is no high-quality evidence to support closing the mesenteric defects

Table 1. Operation Rate for Small Bowel Obstruction Time

30 d, %

1 y, %

2 y, %

0.7

1.6

5

1.8

0.9

2.5

defects left open Mesenteric defects closed

during RYGBP (2013;9:854-855).

In the new study, investigators from 12 bariatric centers in Sweden randomized 2,508 patients undergoing antecolic, antegastric laparoscopic RYGBP to either closure of the mesenteric defects with running, nonabsorbable sutures (1,259 patients) or no closure (1,248 patients). The study monitored patients through the Scandinavian Obesity Surgery Registry database. So far, data have been collected for two years of follow-up and patients will be followed up to five years.

“We compared our data with data from the Swedish National Patient Register, in order to minimize the risk for missing events or serious complications, and bowel obstruction in particular,” said Erik Stenberg, MD, Department of Surgery, Örebro University Hospital, Örebro, Sweden, who presented the study at Obesity Week.

Approximately 75% of patients were women. The average age was 41.7 years, and the average body mass index was 42.3 kg/m2. The two trial arms were well

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Extended Quarterly Coverage

Table 2. Cumulative Incidence Of Internal Hernia Time

30 d

1y

2y

0.2

1.1

4.5

0.2

0.8

1.9

defects left open, % Mesenteric defects closed, %

balanced in terms of comorbidities such as sleep apnea, hypertension, diabetes, dyslipidemia, depression and previous venous thromboembolism. Patient follow-up was 97.3% at one year and 88.4% at two years.

“If we look at the primary end point in our study, which was reoperation for bowel obstruction, in the early postoperative stage, the first 30 days after the operation, there was an increased risk for reoperation with bowel obstruction when the defects were closed,” said Dr. Stenberg (Table 1). He attributed the higher rate in the closure group to the increased kinking of the jejunojenunostomy in this group (1.4% vs. 0.5%; P P=0.015). “This was directly caused by the suturing of the mesenteric defect,” said Dr. Stenberg.

The incidence of reoperation for bowel obstruction was approximately the same at one year, but after two years, it was more common in the nonclosure group.

“The benefit of closing the defect comes over time. At two years, there was a markedly reduced risk for operation for bowel obstruction due to internal hernia when the defects were closed,” said Dr. Stenberg. The risk for internal hernia rose with time in both groups, but more so when the defects were left open (Table 2).

The average operating time was 14 minutes longer in patients who had their defects closed (83.3 vs. 69.6 minutes; P<0.001), but this did not increase the risk for intraoperative complications such as bowel injuries or bleeding, according to the researchers. There was no difference in hospital stays or complications experienced in the first 30 days postsurgery between the groups.

“By closing the mesenteric defects in laparoscopic gastric bypass surgery, the risk for reoperation for bowel obstruction due to internal hernia can be reduced.

The price for doing this is a longer operating time and an increased risk for early bowel obstruction due to kinking jejunojenunostomy,” said Dr. Stenberg. “Further studies are needed to evaluate the optimal method for closure of the mesenteric defects.”

Dr. Pomp said he hoped the researchers continued to follow the patients further, as he expected to see more hernias with longer follow-up.

BARIATRIC BRAIN jContinued from page 31

with improvements in inflammatory markers at three months, triglyceride/ high-density lipoprotein (HDL) ratio (r=0.603; r P=0.006) and C-reactive proP tein (r=0.538; r P=0.021), as well as the P percentage excess weight lost (r=0.452; r P=0.035) at three months.

P “All of the patients lost weight at the usual rate that we expect, roughly about 70% of their excess weight in one year,” said Dr. Morton. “Triglycerides and HDL are markers for metabolic

syndrome. Think of a lot of these [neural] pathways as being like highways.

When you have all that inflammation, you have a clogged highway, and the normal processes are just slower,” said Dr. Morton. “The neurons are preoccupied with inflammatory markers and aren’t doing their usual job.”

The bottom line, said Dr. Morton, is that before bariatric surgery, patients scored well below the national norms on cognitive tests, and after surgery, they normalized or scored similarly to their nonobese peers. These improvements were tied to inflammation and MetS.

John Gunstad, PhD, associate professor in the Department of Psychological Sciences, Kent State University, Kent, Ohio, has been studying neurocognitive function as it relates to cardiovascular disease and obesity for the past 10 years.

“Although obesity is bad for your brain, losing weight can help improve your memory and other mental abilities,” Dr. Gunstad told General Surgery News. “This study provides another clue toward understanding how the weight loss following bariatric surgery helps to improve brain function.”

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In the News

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Gastric Surgery for Diabetes Deemed Very Safe High-Protein Diet Table 1. Baseline Characteristics of Spurs Metabolism, Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass But Effect Is Fleeting B Y K ATE O’R OURKE

BOSTON—An analysis of a national surgical database has concluded that laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery for type 2 diabetes has a complication and mortality rate comparable to some of the safest and most commonly performed surgeries in the United States, such as cholecystectomy, hysterectomy and total knee replacement.

The study was reported at Obesity Week (abstract A701) with simultaneous publication in Diabetes, Obesity, and Metabolism (2014 Oct 29. [Epub ahead of print]).

“The risk-to-benefit ratio of gastric bypass for diabetes and obesity is very favorable. There’s significant weight loss, diabetes improvement or remission and a relatively low complication and mortality rate,” said lead investigator Ali Aminian, MD, a bariatric surgeon from the Cleveland Clinic in Ohio.

According to Dr. Aminian, at least five randomized controlled trials have demonstrated that bariatric surgery has a striking impact on type 2 diabetes, with respect to glycemic control, cardiovascular risk factor modification and, possibly, long-term, complete remission of progressive disease. However, the safety of metabolic/diabetes surgery has been debated; the surgical risk has not been well characterized.

In the new study, investigators used the American College of Surgeons’ National Surgical Quality Improvement Program (ACS-NSQIP) database.

ACS-NSQIP collects data on more than 150 variables, including 30-day postoperative morbidity and mortality outcomes for patients undergoing major surgical procedures in the United States.

The researchers collected data for patients with diabetes undergoing LRYGB (CPT codes 43644 and 43645) between January 2007 and December 2012. For the same period, the researchers also collected data on patients with diabetes undergoing seven other surgeries: coronary artery bypass graft, infrainguinal peripheral vascular revascularization, various laparoscopic procedures (partial colectomy, cholecystectomy, appendectomy and hysterectomy) and total knee arthroplasty.

Overall, 66,678 patients with diabetes were included in the study, 16,509 of whom underwent LRYGB (Table 1). The 30-day postoperative composite complication was defined as the presence of any of nine serious adverse events: pneumonia, acute renal failure, myocardial infarction, deep vein thrombosis, sepsis, pulmonary embolism, septic shock, stroke and need for transfusion.

In patients undergoing LRYGB, the composite complication rate was 3.43%, with some patients having more

Mortality by surgical procedure.

Female, %

71.5

Average age, y

B Y M ONICA J. S MITH

50

Average body mass index, kg/m

2

46.5

Insulin use, %

37.4

Hypertension, %

79

Average American Society of Anesthesiologists score

2.9

Table 2. Complications of Laparoscopic Roux-en-Y Gastric Bypass Outcome

Rate, %

Transfusion

1.22

Sepsis

0.81

Pneumonia

0.66

Deep vein thrombosis

0.36

Septic shock

0.30

Acute renal failure

0.22

Pulmonary embolism

0.22

Myocardial infarction

0.16

Stroke

0.05

than one complication (Table 2); the mortality rate was 0.30%; the average operating time was 137 minutes; and the average hospital length of stay (LOS) was 2.57 days. The 30-day readmission and reoperation rate after LRYGB was 6.72% and 2.46%, respectively.

The LRYGB composite complication rate was similar to the rate seen in laparoscopic cholecystectomy and hysterectomy procedures. Mortality rates from gastric bypass and knee arthroplasty were comparable (Figure 1). Patients undergoing LRYGB and laparoscopic appendectomy had similar hospital LOS and readmission rates. Gastric bypass patients had significantly better short-term outcomes in all examined variables compared with coronary artery bypass graft, infrainguinal revascularization and laparoscopic colectomy.

“The findings of this study indicate that the 30-day mortality risk for LRYGB is one-tenth that of cardiovascular surgery,” Dr. Aminian said. “Earlier intervention with metabolic/diabetes surgery to treat diabetes and metabolic syndrome may eliminate the need for some later higher-risk procedures to treat cardiovascular complications of diabetes.”

Other clinicians were impressed with the study. “One of the biases against bariatric surgery is that there is a high complication and mortality [rate], and this study proves that is not true, at least in the month after surgery,” said Ricardo Cohen, MD, Oswaldo Cruz Hospital and Marcia Maria Braido Hospital, São Paulo, Brazil.

Bipan Chand, MD, director of metabolic and bariatric surgery at the Stritch School of Medicine, Loyola University, Chicago, said he “hoped the study would alert physicians to the safety of current bariatric procedures.”

B

OSTON—A

high-protein diet may spark a person’s metabolism, causing it to burn more calories in the process of digestion than it would with a standard diet, and may result in enhanced storage of lean muscle tissue. Alas, this effect disappears immediately once a person resumes a normal diet, according to new research presented at the Obesity Society annual meeting.

“This study is one more nail in the coffin for the magic bullet for eating everything we want without gaining weight,” said Dale Schoeller, MD, professor emeritus of nutritional sciences at the University of Wisconsin, in Madison. “It’s the holy grail of metabolism research, but it’s always come up negative.”

To investigate the thermic effect of food (TEF) on metabolism, researchers at the Pennington Biomedical Research Center in Baton Rouge, g La., conducted a post hoc analysis of an ovverfeeding study published by Bray et al, which investigated the composition of weight gain in individuals fed low-, normal or high-protein diets ((JAM MA 2012;307:47-55).

“It was an inset study, veery expensive and highly controlled, so it gave us an opportunity to examine the question of wheth-er there is a difference between n the diets’ effect on metabolism,”” said lead researcher Elizabeth h Frost, a PhD candidate at Pen nnington Research Center.

In the original research, participants consumed a weight-stabiliizing diet for 13 to 25 days and were then n randomized to eight weeks of low-, normal or high-protein diets (containing 5%, 15% and 25% protein, respectively), with an excess caloric intake 40% greater than their maintenance diet.

All participants gained weight, but the composition of weight gain varied considerably across the three groups. Those who were fed the low-protein diet stored 95% of their excess calories as fat, whereas those who consumed the high-protein diet stored 50% of their excess calories as fat. The researchers concluded that calories alone increased body fat, whereas protein increased lean body mass and energy expenditure.

Ms. Frost and her colleagues were interested in the possibility of nutritional programming in adults— whether a high- or low-protein diet could influence metabolic inefficiency or metabolic efficiency. “We wanted to see if the metabolic increase you’d normally see with a high-protein diet—the TEF—had residual effects after you return to a normal diet. Can we program our metabolism to maintain that energy expenditure when it’s breaking down food?”

To investigate their hypothesis that the TEF is elevated following high protein intake and to further see PROTEIN PAGE 37

Classifieds

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Expanding Laparoscopic/Bariatric Practice Seeking BC/BE fellowship trained laparoscopic surgeon to join group of two surgeons. Senior surgeon fellowship trained in Laparoscopy in self-established practice for last thirteen years. Second surgeon fellowship trained in Bariatric Surgery from Cleveland Clinic. Work at four area hospitals. Cases include general surgery, advanced laparoscopy, and Bariatric Surgery (hiatal hernias, Nissen fundoplication, Heller myotomy, lap cholecystectomy, CBDE, lap appendectomy, lap colon, lap ventral & inguinal hernias, lap spleen, lap gastric bypass, sleeve and lap band).

Position offers: Three year contract w/instruction in practice management Salary with additional CME reimbursement Medical/Dental coverage Malpractice insurance coverage during course of employment Reasonable call schedule Generous amount of personal time off

SURGICAL & WOUND CARE SURGEONS NEEDED FOR EXPANDING NATIONWIDE SURGICAL PRACTICE: U Ă&#x2022;Â?Â? Ă&#x152;Â&#x2C6;Â&#x201C;i Â&#x153;Ă&#x20AC; ÂŤ>Ă&#x20AC;Ă&#x152; Ă&#x152;Â&#x2C6;Â&#x201C;i ÂŤÂ&#x153;Ă&#x192;Â&#x2C6;Ă&#x152;Â&#x2C6;Â&#x153;Â&#x2DC;Ă&#x192; >Ă&#x203A;>Â&#x2C6;Â?>LÂ?i U Ä?`` Ă&#x20AC;iĂ&#x203A;iÂ&#x2DC;Ă&#x2022;i Ă&#x152;Â&#x153; Ă&#x17E;Â&#x153;Ă&#x2022;Ă&#x20AC; VĂ&#x2022;Ă&#x20AC;Ă&#x20AC;iÂ&#x2DC;Ă&#x152; ÂŤĂ&#x20AC;>VĂ&#x152;Â&#x2C6;Vi UÄ&#x152; Â?iĂ?Â&#x2C6;LÂ?i Ă&#x192;VÂ&#x2026;i`Ă&#x2022;Â?i] VÂ&#x153;Â&#x201C;ÂŤÂ?iĂ&#x152;i >Ă&#x2022;Ă&#x152;Â&#x153;Â&#x2DC;Â&#x153;Â&#x201C;Ă&#x17E; U Â&#x153; V>Â?Â?

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Local Environment â&#x20AC;˘ Located on the north shore of Long Island, 60 miles outside of NYC â&#x20AC;˘ NYC accessible by car and LIRR â&#x20AC;˘ Township population: 1/2 million people â&#x20AC;˘ Excellent local school districts â&#x20AC;˘ Abundance of local attractions and family friendly environment â&#x20AC;˘ Nearest airport within twenty miles OFFICES LOCATED AT 4 Technology Drive, East Setauket, NY 11733 Websites: www.JourneyToTheNewYou.com and www.LILapDoc.com

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Hyatt French Quarter, New Orleans, LA with optional post-symposium sessions March 23-24, 2015

Invited Speakers include:

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¡ ¡ ¡ ¡ ¡ ¡

¡ Ultrasound Hands-on workshop ¡ Video presentations on How I do it

Patrick Aidan, American Hospital of Paris Eren Berber, Cleveland Clinic David Cooper, Johns Hopkins University Robert L. Ferris, University of Pittsburgh Ashok Shaha, Memorial Sloan Kettering Ralph Tufano, Johns Hopkins University

Years

Monday, March 23, 2015: Ultrasound Observations* Tuesday, March 24, 2015: Live Case Observations* *optional

35

36

In the News SMAPPS

jContinued from page 1 computer system—an IBM mainframe designed to keep track of several thousand bank accounts and mortgages. The system filled an entire floor of the building with multiple modules, and storage was on spinning steel with magnetic tape backup. Compared with today, it basically had the brainpower equivalent to that of a nematode worm, but nevertheless it kept accurate records and basic computations without the mistakes of a bank teller.

Today, due to advances in materials, science and miniaturization, we all carry small “supercomputers” in our pockets.

Modern cell phones are close to monkey intelligence and should reach human intelligence in less than a decade. The consequences of this for mankind are enormous and could prove to be one of the greatest tools for scientific, medical and human advancement.

I became an early tinkerer in the development of apps for computers, and published some of the first online medical books and textbooks in the newer interactive eBook format. I thought my role as a developer was unique until in late 2014 when, attending a developer’s

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

conference, Tim Cook, the CEO of Apple, welcomed the 9 million app developers from around the world. He said it was a 47% increase from the previous year.

A part of this large group is working on scientific and medical problems and solving them with what I call “Smapps,” short for scientific and medical apps.

Smapps are being designed to work with every kind of scientific and medical sensor you can imagine, and to collect and analyze vast quantities of data from large numbers of people. Although we are only in the early stages of this trend, there are already a very large number of medical and scientific tools that work on most smartphones. These include ultrasonic transducers, oscilloscopes, retinal imagers, spectrometers, blood chemistry analyzers, vital sign trackers and many more. Many of these apps will revolutionize the way physicians and patients interact, and many will even help them improve patient safety and achieve better outcomes.

This article is the first review in a series that will examine some of these apps and illuminate why we should have them and what they can offer us.

SafeStart by SPOT, LLC. is a Smapp that works on the Apple iPad iOS. It is

SafeStart: An O.R. Scheduling App. the brainchild of University of Chicago surgeon Richard Vazquez, MD, whose goal was to create a HIPAA-compliant app to increase safety, reduce errors, and save time and money.

SafeStart software has the capability to coordinate and verify information from the office, patient and surgeon in an effort to eliminate handoff and scheduling errors that can originate in the office or clinic. Each of these groups

can verify the information from most locations, including in the operating room (OR) at the time of surgery.

During the initial consultation, the physician enters the patient’s information into various fields, including name, sex and allergies. The physician then takes a photo of the patient for both patient and surgical site identification.

This information will be used to create the SafeStart timeout checklist at the time of the procedure.

The physician then checks the appropriate boxes and makes any final adjustments. After everything is finalized, the physician signs his or her name and completes the process. The completed checklist can be printed wirelessly, saved to any server or attached electronically to an HL7-compliant electronic medical record.

SafeStart is a medical app with great promise as it uses the advanced functionality of iOS to address many concerns about improving outcomes for surgery in a user-friendly way. It has HIPAA inclusion and portability for office and OR use, and the cost averages out to about $10 per use, which seems reasonable. More information can be found on the company website safestartmedical.com.

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2015

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2015

PROTEIN

jContinued from page 34 determine whether that elevation is short-lived or prolonged, the researchers evaluated Bray et al’s study data on the participants’ TEF, which was captured by indirect calorimeter for a four-hour period after meals.

In the first two to four weeks of the assigned diets, resting energy expenditure did not change in the low-protein group, but increased significantly in the normal and high-protein groups. At six weeks, participants were fed a standard meal, similar to what they had eaten at baseline. All reverted to their baseline resting energy expenditure. “We found that there was no difference at all in the thermic effect of food,” Ms. Frost said.

On the final day of overfeeding, measurements were taken once more. “But instead of challenging them with a standard meal, we gave them their study diet—so if they were on the low-protein diet, they got a low-protein meal; if they were on the high-protein diet, they had a high-protein meal that morning,” Ms. Frost said. “We found that, as the literature supports, those who were on the high-protein diet experienced a doubling of the thermic effect of food.

“We showed acutely that if you eat a high-protein diet, you have an elevated thermic effect of food. If you prolong that diet, you maintain the increased effect. But as soon as you revert to a normal diet, the increased expenditure goes away. Your body doesn’t save that elevation.”

Ms. Frost and her colleagues concluded that although TEF is influenced by protein intake, prolonged exposure to a high-protein diet does not alter the body’s response to a standard meal.

Therefore, TEF is probably very tightly regulated and cannot be reprogrammed.

As for the study’s applicability, Ms. Frost pointed out that although the Bray research was an overfeeding model, it supports something many Atkins diet followers have experienced. “The evidence is that it works, that you can achieve energy expenditure not only by exercising but by increasing the amount of protein in your diet,” Ms. Frost said.

“But it’s important to know that the positive effects of a high-protein diet are not saved by your body, and that if you want to maintain the benefits, you have to maintain the diet.”

The study’s findings were not surprising to Lee M. Kaplan, MD, PhD, director of the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital in Boston.

“The belief that you could change your diet for a finite period of time and reprogram the human body is not a realistic strategy,” he said. “But this paper, on

‘The evidence is that it works, that you can achieve energy expenditure not only by exercising but by increasing the amount of protein in your diet.’

the background of a great deal of previous research, provides important new information that helps us define the physiologic response of the body to different diets.

If it were as simple as shifting to a high-protein diet for a brief period, we would have been a lot more successful in the last 40 years than we have been.”

—Elizabeth Frost, PhD Candidate

•

2015

•

The American Society of Colon and Rectal Surgeons

Annual Scientific Meeting May 30 - June e 3, 2015 H nes Convention Center & Sheraton Hyn n Boston Ho otel

Program available online in February at www.fascrs.org

37

38

In the News SINGLE-INCISION jContinued from page 1

single-incision laparoscopic cholecystectomy (SILC) compared with the four-port operation (LC), the study showed. Overall physical workload, mental demand and task complexity were also higher with the single-incision procedure, although it was not found to be statistically significant. â&#x20AC;&#x153;The torque that is needed for singleincision cholecystectomy because of parallel instruments is higher, resulting in increased workload,â&#x20AC;? said senior investigator Juliane Bingener-Casey, MD, a

gastroenterologic surgeon at Mayo Clinic. Dr. Bingener-Casey performed all the operations included in the study.

Other surgeons disagree with the findings, saying that single-incision surgery can be performed without adding further ergonomic stress on the surgeon, provided the operating space is set up properly.

Sharona Ross, MD, director of surgical endoscopy and minimally invasive surgery and director of the Advanced GI and HPB Fellowship Program at Florida Hospital in Tampa, now performs more single-incision foregut and hepatopancreatobiliary operations than traditional

â&#x20AC;&#x2DC;If the set up is right, the rest is easy both cognitively and ergonomically. Furthermore, you donâ&#x20AC;&#x2122;t need multiple people to assist you.â&#x20AC;&#x2122; â&#x20AC;&#x201D;Sharona Ross, MD multiport laparoscopy and, with her partner, has trained more than 300 surgeons in the technique since 2007. â&#x20AC;&#x153;Ergonomically, single-incision laparoscopy is set up perfectly when you have

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-RQ *RXOG 0' Chief, Division of General Surgery Alonzo P. Walker Chair in Surgery Professor of Surgery Medical College of Wisconsin Senior Medical Director of Clinical Affairs Froedtert Hospital Milwaukee, Wisconsin

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Supported by an educational grant from Merck.

Sharona Ross, MD, right, performing a laparoendoscopic single-site cholecystectomy. Dr. Ross believes that proper set-up of equipment can help surgeons avoid the potential negative ergonomic effects of single-incision surgery. your screen and instruments positioned right,â&#x20AC;? she said. â&#x20AC;&#x153;My instruments come directly toward me at the level of my umbilicus without having my arms up in different directions. My screen is set to my height and positioned right in front of me. Itâ&#x20AC;&#x2122;s a matter of setup.â&#x20AC;? â&#x20AC;&#x153;Once you acquire the appropriate tool box and figure out which instrument goes in which multitrocar port, there is no clashing of instruments and great range of motion. If the setup is right, the rest is easy both cognitively and ergonomically. Furthermore, you donâ&#x20AC;&#x2122;t need multiple people to assist you.â&#x20AC;?

But many surgeons have complained about the ergonomics of single-incision laparoscopic surgery. Studies describe a reduced ability to triangulate instrumentation, resulting in internal and external clashing. â&#x20AC;&#x153;Operating with a camera and instruments in parallel also causes ergonomic discomfort. For these reasons, concerns have been raised about the safety of this technique (JSLS ( S 2010;14:587-591) and mass adoption of single-incision laparoscopic surgery has not occurred,â&#x20AC;? surgeons said in a study in Archives of Surgery in 2012 (147:709-714). In 2013, oneyear results of a prospective randomized, multicenter, single-blinded trial of traditional multiport laparoscopic cholecystectomy versus SILC found SILC was associated with improved cosmesis but with significantly higher hernia rates ( (JACS 2013;216:1037-1047). Only one of 81 patients who received standard laparoscopy developed a hernia (1.2%) versus 10 of 119 patients (8.4%) who underwent the single-incision procedure (P=0.03).

P This new study, although small, took a unique approach to assessing surgical workload with single-incision laparoscopic surgery. Researchers performed a twopart, double-blind, randomized controlled

In the News ‘In the near future [singleincision laparoscopic cholecystectomy] could overrule conventional [laparoscopic surgery] as the leading technique for gallbladder surgery.’

—Surg Laparosc Endosc Percutan Tech 2014 trial that looked at SILC and four-port LC. For the portion of the study that measured surgeon workload, researchers examined 48 procedures performed by a single surgeon.

The surgeon underwent salivary cortisol testing before, during and after the procedure, along with continuous heart rate monitoring. After the operation, the surgeon completed the Surgical Task Load Index (Surg-TLX), a validated tool that measures perceived workload and is based on a similar questionnaire developed by NASA’s human performance group. SurgTLX assesses mental demands, physical demands, temporal demands, task complexity, situational stress and distractions.

Surgeon workload increased by 53% for SILC compared with LC, although the difference was not statistically significant.

Surg-TLX subscore analysis, using 100port scales, found that physical workload was a median of 42.5 for SILC, nearly twice the 22.5 reported for LC (P=0.018).

P The surgeon also reported a statistically significant increase in awkwardness to manipulate instruments and less ability to perform fine-precision motions for SILC. The surgeon’s heart rate and salivary cortisol were higher after SILC compared with LC. Results did not vary based on sex, age or body mass index. Operative duration did not differ between the two approaches, suggesting that the surgeon’s learning curve had already been overcome.

The study was done as part of a larger trial in which 110 patients were randomized to undergo SILC or LC. All operations were elective procedures. The patient-focused portion of the study, which was presented in November 2014 at the Western Surgical Association meeting, concluded that operative approach did not affect patients’ postoperative pain scores. Patients who underwent a fourport operation reported significantly less fatigue on postoperative day 7 than those in the single-port group (3.1±2.1 vs.

4.2±2.2; P=0.009).

P “It is possible that both the patient and the surgeon were more fatigued after single-port procedures,” the investigators concluded.

The study did not address cosmesis,

which is often touted as a key advantage for single-incision laparoscopy. Investigators noted that the results are not generalizable to other single-port procedures.

In a December 2014 report, Austrian surgeons described the results of a study of 875 prospective patients who underwent SILC (n=201) or four-port LC (n=674) (Surg Laparosc Endosc Percutan Tech 2014;24:e207-e210). Mean operative time was significantly lower in the SILC group (SILC, 71±31 vs. LC, 79±27 minutes) and duration of postoperative hospital stay was shorter (SILC, 3.2±1.7 vs. LC, 4.5±2.6 days). No significant

difference was observed between SILC and LC in any of the registered complications, including postoperative bleeding, trocar hernias, wound infection, abdominal abscess formation, bile duct injury or cystic duct leakage.

“In the near future, SILC could overrule conventional LC as the leading technique for gallbladder surgery. Our data reconfirm an excellent risk profile for SILC that is equal to that of LC. Large multicenter randomized controlled trials will be required to finally legitimize SILC as the succeeding principal method,” they concluded.

BRIEF SUMMARY OF PRESCRIBING INFORMATION

ENTEREG® (alvimopan) capsules, for oral use The following is a brief summary only; see full prescribing information for complete product information.

WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY There was a greater incidence of myocardial infarction in alvimopan-treated patients compared to placebo-treated patients in a 12-month clinical trial, although a causal relationship has not been established. In short-term trials with ENTEREG®, no increased risk of myocardial infarction was observed.

Because of the potential risk of myocardial infarction with long-term use, ENTEREG is available only through a restricted program for short-term use (15 doses) under a Risk Evaluation and Mitigation Strategy (REMS) called the ENTEREG Access Support and Education (E.A.S.E.®) Program.

INDICATIONS AND USAGE ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.

CONTRAINDICATIONS ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG. WARNINGS AND PRECAUTIONS Potential Risk of Myocardial Infarction with Long-term Use There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic non-cancer pain (alvimopan 0.5 mg, n = 538; placebo, n = 267). In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment.

This imbalance has not been observed in other studies of ENTEREG in patients treated with opioids for chronic pain, nor in patients treated within the surgical setting, including patients undergoing surgeries that included bowel resection who received ENTEREG 12 mg twice daily for up to 7 days (the indicated dose and patient population; ENTEREG 12 mg, n = 1,142; placebo, n = 1,120). A causal relationship with alvimopan with long-term use has not been established.

ENTEREG is available only through a program under a REMS that restricts use to enrolled hospitals.

E.A.S.E. ENTEREG REMS Program ENTEREG is available only through a program called the ENTEREG Access Support and Education (E.A.S.E.) ENTEREG REMS Program that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of ENTEREG. Notable requirements of the E.A.S.E. Program include the following: ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have enrolled in and met all of the requirements for the E.A.S.E. program may use ENTEREG. To enroll in the E.A.S.E. Program, an authorized hospital representative must acknowledge that: hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use; patients will not receive more than 15 doses of ENTEREG; and ENTEREG will not be dispensed to patients after they have been discharged from the hospital.

Further information is available at www.ENTEREGREMS.com or 1-877-282-4786.

Gastrointestinal-Related Adverse Reactions in Opioid-Tolerant Patients Patients recently exposed to opioids are expected to be more sensitive to the effects of μ-opioid receptor antagonists, such as ENTEREG. Since ENTEREG acts peripherally, clinical signs and symptoms of increased sensitivity would be related to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea). Patients receiving more than 3 doses of an opioid within the week prior to surgery were not studied in the postoperative ileus clinical trials. Therefore, if ENTEREG is administered to these patients, they should be monitored for gastrointestinal adverse reactions. ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG. Risk of Serious Adverse Reactions in Patients with Severe Hepatic Impairment Patients with severe hepatic impairment may be at higher risk of serious adverse reactions (including dose-related serious adverse reactions) because up to 10-fold higher plasma levels of drug have been observed in such patients compared with patients with normal hepatic function.

Therefore, the use of ENTEREG is not recommended in this population.

End-Stage Renal Disease No studies have been conducted in patients with end-stage renal disease. ENTEREG is not recommended for use in these patients.

Risk of Serious Adverse Reactions in Patients with Complete Gastrointestinal Obstruction No studies have been conducted in patients with complete gastrointestinal obstruction or in patients who have surgery for correction of complete bowel obstruction. ENTEREG is not recommended for use in these patients.

Risk of Serious Adverse Reactions in Pancreatic and Gastric Anastomoses ENTEREG has not been studied in patients having pancreatic or gastric anastomosis.

Therefore, ENTEREG is not recommended for use in these patients.

ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The data described below reflect exposure to ENTEREG 12 mg in 1,793 patients in 10 placebo-controlled studies. The population was 19 to 97 years old, 64% were female, and 84% were Caucasian; 64% were undergoing a surgery that included bowel resection. The first dose of ENTEREG was administered 30 minutes to 5 hours before the scheduled start of surgery and then twice daily until hospital discharge (or for a maximum of 7 days of postoperative treatment).

Among ENTEREG-treated patients undergoing surgeries that included a bowel resection, the most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%). Adverse reactions are events that occurred after the first dose of study medication treatment and within 7 days of the last dose of study medication or events present at baseline that increased in severity after the start of study medication treatment.

DRUG INTERACTIONS Potential for Drugs to Affect Alvimopan Pharmacokinetics An in vitroo study indicates that alvimopan is not a substrate of CYP enzymes. Therefore, concomitant administration of ENTEREG with inducers or inhibitors of CYP enzymes is unlikely to alter the metabolism of alvimopan.

Potential for Alvimopan to Affect the Pharmacokinetics of Other Drugs Based on in vitroo data, ENTEREG is unlikely to alter the pharmacokinetics of coadministered drugs through inhibition of CYP isoforms such as 1A2, 2C9, 2C19, 3A4, 2D6, and 2E1 or induction of CYP isoforms such as 1A2, 2B6, 2C9, 2C19, and 3A4.

In vitro, ENTEREG did not inhibit p-glycoprotein.

Effects of Alvimopan on Intravenous Morphine Coadministration of alvimopan does not appear to alter the pharmacokinetics of morphine and its metabolite, morphine-6-glucuronide, to a clinically significant degree when morphine is administered intravenously. Dosage adjustment for intravenously administered morphine is not necessary when it is coadministered with alvimopan.

Effects of Concomitant Acid Blockers or Antibiotics A population pharmacokinetic analysis suggests that the pharmacokinetics of alvimopan were not affected by concomitant administration of acid blockers or antibiotics. No dosage adjustments are necessary in patients taking acid blockers or antibiotics.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B Risk Summary: y There are no adequate and/or well-controlled studies with ENTEREG in pregnant women. No fetal harm was observed in animal reproduction studies with oral administration of alvimopan to rats at doses 68 to 136 times the recommended human oral dose, or with intravenous administration to rats and rabbits at doses 3.4 to 6.8 times, and 5 to 10 times, respectively, the recommended human oral dose. Because animal reproduction studies are not always predictive of human response, ENTEREG should be used during pregnancy only if clearly needed.

Animal Data: Reproduction studies were performed in pregnant rats at oral doses up to 200 mg/kg/day (about 68 to 136 times the recommended human oral dose based on body surface area) and at intravenous doses up to 10 mg/kg/day (about 3.4 to 6.8 times the recommended human oral dose based on body surface area) and in pregnant rabbits at intravenous doses up to 15 mg/kg/day (about 5 to 10 times the recommended human oral dose based on body surface area), and revealed no evidence of impaired fertility or harm to the fetus due to alvimopan.

Nursing Mothers It is not known whether ENTEREG is present in human milk. Alvimopan and its ‘metabolite’ are detected in the milk of lactating rats. Exercise caution when administering ENTEREG to a nursing woman.

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Geriatric Use Of the total number of patients in 6 clinical efficacy studies treated with ENTEREG 12 mg or placebo, 46% were 65 years of age and over, while 18% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment based on increased age is required.

Hepatic Impairment ENTEREG is not recommended for use in patients with severe hepatic impairment.

Dosage adjustment is not required for patients with mild-to-moderate hepatic impairment.

Patients with mild-to-moderate hepatic impairment should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur.

Renal Impairment ENTEREG is not recommended for use in patients with end-stage renal disease. Dosage adjustment is not required for patients with mild-to-severe renal impairment, but they should be monitored for adverse effects. Patients with severe renal impairment should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur.

Race No dosage adjustment is necessary in Black, Hispanic, and Japanese patients. However, the exposure to ENTEREG in Japanese healthy male volunteers was approximately 2-fold greater than in Caucasian subjects. Japanese patients should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur.

ENTEREG and E.A.S.E. are trademarks of Cubist Pharmaceuticals. Any other trademarks are property of their respective owners.

Distributed by: Cubist Pharmaceuticals U.S. Lexington, MA 02421 USA © Cubist Pharmaceuticals. All rights reserved.

October 2014 ENT-0232

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Experience the ENTEREG EFFECT ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal (GI) recovery following surgeries that include partial bowel resection with primary anastomosis.1

› In clinical trials, ENTEREG added to an accelerated care pathway (ACP) was more effective than an ACP alone1 – ENTEREG improved mean time to GI recovery by 11-32 hours vs. placebo1* – ENTEREG also reduced time to discharge order written by 13-22 hours1,2*

ENTEREG improved mean time to GI recovery by up to 20% compared to placebo1* *Data are from 5 multicenter, randomized, double-blind, placebo-controlled studies in patients undergoing bowel resection and 1 study in patients undergoing radical cystectomy. Patients were administered ENTEREG 12 mg or placebo 30 minutes to 5 hours prior to surgery and twice daily after surgery until discharge or a maximum of 7 days. Patients who received more than 3 doses of an opioid (regardless of route) during the 7 days prior to surgery and patients with complete bowel obstruction or who were scheduled for a total colectomy, colostomy, or ileostomy were excluded.1

Important Safety Information for ENTEREG

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WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY Increased incidence of myocardial infarction was seen in a clinical trial of patients taking alvimopan for long-term use. No increased risk was observed in short-term trials Because of the potential risk of Myocardial Infarction, ENTEREG is available only through a restricted program for short-term use (15 doses) called the ENTEREG Access Support and Education (E.A.S.E.®) ENTEREG REMS Program

Contraindications

› ENTEREG Capsules are contraindicated in patients who have

taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG

Warnings and Precautions

› There were more reports of myocardial infarctions in patients

›

treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic pain. In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of alvimopan, including studies of patients undergoing bowel resection surgery who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established ENTEREG should be administered with caution to patients receiving more than 3 doses of an opioid within the week prior to surgery. These patients may be more sensitive

›

to ENTEREG and may experience GI side effects (eg, abdominal pain, nausea and vomiting, diarrhea) ENTEREG is not recommended for use in patients with severe hepatic impairment, end-stage renal disease, complete gastrointestinal obstruction, or pancreatic or gastric anastomosis, or in patients who have had surgery for correction of complete bowel obstruction

Adverse Reactions

› The most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo among ENTEREG-treated patients undergoing surgeries that included a bowel resection was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%)

E.A.S.E.® Program for ENTEREG

› ENTEREG is available only to hospitals that enroll in the

E.A.S.E. Program. To enroll in the E.A.S.E. Program, the hospital must acknowledge that: Hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use Patients will not receive more than 15 doses of ENTEREG ENTEREG will not be dispensed to patients after they have been discharged from the hospital

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Please see following brief summary of Prescribing Information for ENTEREG. References: 1. ENTEREG [package insert]. Lexington, MA: Cubist Pharmaceuticals U.S.; 2014.

2. Lee CT, Chang SS, Kamat AM, et al. Eur Urol. 2014; 66(2):265-272.

©2014 Cubist Pharmaceuticals ENTEREG and E.A.S.E. are registered trademarks of Cubist Pharmaceuticals. www.ENTEREG.com ENT-0229 November 2014